Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-07 @ 11:59 PM
Study NCT ID:
NCT03750006
Status:
TERMINATED
Last Update Posted:
2024-08-30
First Post:
2018-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bruce.troen@va.gov', 'phone': '913-574-4896', 'title': 'Bruce Troen', 'organization': 'VA Kansas City Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Goal of trial was to evaluate recruitment, administration, and safety profile of short session HIIT, and not necessarily the efficacy of the HIIT protocol for functional capacity.\n\nTrial does not have a non-exercise control group Trial features limited number of participants (23), which includes only 1 female Trial was stopped short due to COVID-19 pandemic, 8 of the 23 participants did not complete the total 12 weeks of training although all participants had at least 6 weeks of training.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected weekly over a 14 week period for each participant, commencing from baseline assessments week 0, through the HIIT intervention (weeks 1 - 12 or up to 14), and ending with collection at end-point assessments.', 'eventGroups': [{'id': 'EG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6-minute Walk at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '418.2', 'spread': '72.2', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '436.8', 'spread': '55.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0238', 'groupIds': ['OG000'], 'pValueComment': 'Not adjusted for multiple comparisons, P \\< 0.05 is considered significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired T-test'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': '6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Activity Enjoyment at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3029', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete the assessment due to scheduling conflict.'}, {'type': 'PRIMARY', 'title': 'VO2max at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '18.67', 'spread': '5.12', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '19.93', 'spread': '5.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1713', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Performed as part of a symptom limited maximal endurance test on a cycle ergometer', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants were not able to complete the VO2max end point assessment due to COVID pandemic study cessation.\n\nOne participant was not able to complete the assessment due to scheduling conflict.'}, {'type': 'SECONDARY', 'title': 'Short Physical Performance Battery at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.11', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '10.46', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1261', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frailty at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1367', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss.\n\nThese assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Survey at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '80.0', 'spread': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '85.6', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0111', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': "Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 \\* ((participant's score - 14) / 56).", 'unitOfMeasure': '% of Max Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive Survey at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.6', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '27.3', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0219', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete the assessment due to scheduling conflict.'}, {'type': 'SECONDARY', 'title': 'Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3660', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'microRNA Profiling at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Next Generation Sequencing of microRNA species from serum.', 'reportingStatus': 'POSTED', 'populationDescription': 'RNA was isolated from participant serum samples and sequenced. However, none of the sequenced RNA were microRNA sequences, therefore analysis could not be performed. Consequently, there was no microRNA data that could be presented in a table.'}, {'type': 'SECONDARY', 'title': 'Serum 25-hydroxy-vitamin D at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No Statistical Analysis was performed as this was only a baseline measurement.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein Level at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1563', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA', 'unitOfMeasure': 'ug/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quadriceps Strength at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Right Leg - Baseline', 'categories': [{'measurements': [{'value': '27.7', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Right leg - Endpoint', 'categories': [{'measurements': [{'value': '31.1', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Left leg - Baseline', 'categories': [{'measurements': [{'value': '28.0', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Left Leg - Endpoint', 'categories': [{'measurements': [{'value': '29.9', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0110', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete the assessment due to scheduling conflict.'}, {'type': 'SECONDARY', 'title': 'FRAIL Scale Survey at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3282', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Interleukin-6 Level at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5244', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Interleukin-10 Level at Baseline and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5718', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired, P \\< 0.05 is considered significant.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Muscle Tissue Oxygenation Raw Data Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The goal of this project was to determine if raw functional near infrared spectroscopy data could be collected in participants. Data collection was verified. This work lays the foundation for future efforts in new experiments to determine methods to analyze the raw data to generate understandable data for interpretation - and lead to better understanding of the impacts of exercise on blood flow in muscle tissue.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Recruitment initiated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COVID PANDEMIC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Recruitment from 12/3/2018 - 12/31/2019. Recruitment occurred at the VA Western New York including through posted advertisements and word of mouth.', 'preAssignmentDetails': '11 individuals were excluded due to the COVID pandemic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIIT Intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.\n\nShort session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '0.6076', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'categories': [{'title': 'Non-smoker', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Former Smoker', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-25', 'size': 512967, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-26T14:46', 'hasProtocol': True}, {'date': '2021-11-17', 'size': 206289, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-27T16:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'COVID pandemic halted ability to enroll participants. Grant funded then ended.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2018-11-09', 'resultsFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-07', 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute Walk at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': '6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.'}, {'measure': 'Physical Activity Enjoyment at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.'}, {'measure': 'VO2max at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Performed as part of a symptom limited maximal endurance test on a cycle ergometer'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome.'}, {'measure': 'Frailty at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss.\n\nThese assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".'}, {'measure': 'Quality of Life Survey at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': "Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 \\* ((participant's score - 14) / 56)."}, {'measure': 'Cognitive Survey at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes.'}, {'measure': 'Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support.'}, {'measure': 'microRNA Profiling at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Next Generation Sequencing of microRNA species from serum.'}, {'measure': 'Serum 25-hydroxy-vitamin D at Baseline', 'timeFrame': 'baseline', 'description': 'serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA'}, {'measure': 'C-reactive Protein Level at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA'}, {'measure': 'Quadriceps Strength at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force.'}, {'measure': 'FRAIL Scale Survey at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty.'}, {'measure': 'Serum Interleukin-6 Level at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA'}, {'measure': 'Serum Interleukin-10 Level at Baseline and Endpoint', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA'}, {'measure': 'Number of Participants With Muscle Tissue Oxygenation Raw Data Collected', 'timeFrame': 'baseline and at participant completion, an average of 3 months', 'description': 'Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frailty', 'sarcopenia', 'exercise', 'high intensity', 'older adults', 'microRNA'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.', 'detailedDescription': 'Enhancing functional capacity in older adults with short session high intensity interval training\n\nFrailty is a condition of poor physiological reserve that increases susceptibility to falls, hospitalization, disability and mortality. The incidence of frailty rapidly increases after the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9 million Veterans are either frail or at risk for frailty. Exercise has proven benefits for frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as it delivers similar or better gains than moderate intensity exercise in less time. Recently, the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only reduces frailty, but leads to both strength and endurance benefits. In addition, the preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the potential of short session HIIT to improve functional capacity and lead to better adherence, the modality has not been tested in individuals 65-85 years of age, and in particular, frail individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.\n\nTo accomplish these goals the investigators will administer a short session HIIT regimen totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to 65-85 year old participants. The investigators will also utilize next generation RNA sequence technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators anticipate this project will demonstrate the feasibility of administering short session HIIT to older individuals, including vulnerable frail and pre-frail populations as well as demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this program are the ability to maintain or build muscle mass and improve aerobic conditioning, especially in older patients where frailty and sarcopenia are so prevalent. This pilot project will therefore lay the foundation for future clinical trials that further explore the utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately lead to the enhancement of functional capacity and quality of life in aging Veteran populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Any race\n* Frail, pre-frail, and non-frail\n* Medical clearance for exercise\n\nExclusion Criteria:\n\n* Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))\n* VAMC SLUMS score 20\n* Physical impairment that prevents use of a recumbent exercise bike'}, 'identificationModule': {'nctId': 'NCT03750006', 'acronym': 'HIIT-VA', 'briefTitle': 'Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training', 'orgStudyIdInfo': {'id': 'E2902-P'}, 'secondaryIdInfos': [{'id': 'RX002902', 'type': 'OTHER_GRANT', 'domain': 'Veteran Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT intervention', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.', 'interventionNames': ['Behavioral: Short session HIIT']}], 'interventions': [{'name': 'Short session HIIT', 'type': 'BEHAVIORAL', 'description': 'Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.', 'armGroupLabels': ['HIIT intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'VA Western New York Healthcare System, Buffalo, NY', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Bruce R. Troen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Western New York Healthcare System, Buffalo, NY'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Six months after publication.', 'ipdSharing': 'YES', 'description': 'Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.', 'accessCriteria': 'Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'The VA Western New York Healthcare System', 'class': 'FED'}, {'name': 'University at Buffalo', 'class': 'OTHER'}, {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}