Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT02331459
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2015-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Intervention in a Controlled Population of Frail Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-31', 'studyFirstSubmitDate': '2015-01-03', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geriatric Depression Scale', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': 'Change from baseline to the end of the intervention, and the change between the intervention group and the control group.'}, {'measure': 'Quality of life: EuroQol-5D', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': 'Change from baseline to the end of the intervention, and the change between the intervention group and the control group.'}, {'measure': 'Composite effect of a multicomponent training intervention on systemic biomarkers of frailty', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': '* Plasma malondialdehyde (High performance liquid chromatography)\n* Plasma oxidized proteins (Western blotting)\n* serum interleukin (IL)-6 and tumor necrosis factor (TNF)-α (ELISA Kits)\n* Plasma GDF-11 (Western Blotting)\n* Plasma Meterorin-like (ELISA kit)'}], 'primaryOutcomes': [{'measure': 'Activities of daily living.', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': 'The primary study endpoint is the change from baseline to the end of the intervention, and the change between the intervention group and the control group, in score of Barthel Activities of Daily Living Index and the Lawton Instrumental Activities of Daily Living Scale'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': 'Change from baseline to the end of the intervention, and the change between the intervention group and the control group.'}, {'measure': 'Short Physical Performance Battery and Physical Performance Test', 'timeFrame': 'Day 0 and Day 180 (plus or minus 3 days)', 'description': 'Change from baseline to the end of the intervention, and the change between the intervention group and the control group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mood', 'cognitive state', 'physical activity', 'frailty'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '26947059', 'type': 'DERIVED', 'citation': 'Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it is not known physical training pattern more beneficial for these patients. The reasons for heterogeneity and lack of consistency of the results described by published intervention programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings - or a combination of them. There are no studies with a combined program of this three kinds of physical training.\n\nThe objective of this study is to know if a multicomponent physical training program during 180 days in dwelling-community frail geriatric patients can improve scores on functional, activities of daily living, mood, cognitive and quality of life scales and producing changes in blood levels of biological and genetic markers.', 'detailedDescription': 'At the start of recruitment, a comprehensive geriatric assessment will be developed in enrolled patients of both groups. After this assessment and before starting the physical training in intervention group, a nutritional intervention will be provided in patients of both groups :\n\nEnrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.\n\nAs well as, calcium and vitamin D will be provided if calcidiol blood levels are lower than 30 ng/ml.\n\nCalcidiol blood value between 20-29 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 15 days (3 months)\n\nCalcidiol blood value between 10-19 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 10 days (3 months)\n\nCalcidiol blood value between 1-9 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 7 days (3 months)\n\nAfter nutritional intervention, intervention group will start a multicomponent training intervention during 180 days Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)\n\nLegend:\n\nmin. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% HRmax c = Strength training arms and legs d = Stretching Characteristics of the strength training Month 1 Week 1 25% 1-RM 1x30 r Week 2 25% 1-RM 2x30 r Week 3-4 25% 1-RM 3x30 r Month 2 Week 1-4 25% 1-RM 3x30 r Month 3 Week 1 50% 1-RM 1x15 r Week 2 50% 1-RM 2x10 r Week 3-4 50% 1-RM 3x8 r Month 4 Week 1-4 50% 1-RM 3x8 r Month 5 Week 1 75% 1-RM 1x15 r Week 2 75% 1-RM 2x10 r Week 3-4 75% 1-RM 3x8 r Month 6 Week 1-4 75% 1-RM 3x8 r\n\nLegend:\n\n1-RM: One-repetition maximum r: repetitions\n\nMonthly, enrolled frail elderly patients will be evaluated. 6 minutes walking test, timed up and go test, bilateral hand grip, Barthel index, Tinetti balance assessment tool, Mini-mental state examination, short-MNA (Mini Nutritional Assessment ), lean and fat mass measures with impedanciometer and number of visits to general practitioner, emergency room and hospital admission were recorded.\n\nAfter follow up period a new comprehensive geriatric assessment will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- Dwelling-community subjects\n2. \\- Age 70 years old and older\n3. Frail geriatric patient according to the Cardiovascular Health Study (CHS) Frailty Phenotype\n4. Gait speed less than 0.8 m/s.\n\nExclusion Criteria:\n\n1. \\- Life expectancy less than 6 months for any clinical reason (we considered criteria of a life expectancy less than 6 months 7 c-7 d global deterioration degree on GDS (Global Deterioration Scale)-FAST (Functional Assessment Staging ) scale in patients with dementia; severe disabilities considered as score less than 15 points in Barthel index and left ventricular ejection fraction equal or less than 20%)\n2. \\- Hospital Admission in the last 3 months for any clinical reason\n3. \\- oncologic patients in chemotherapy or radiotherapy active treatment\n4. \\- Major surgery in the last 6 months\n5. \\- First-degree centenary relatives in the two previous generations\n6. \\- Ischemic coronary event in the last 12 months\n7. Institutionalized subjects\n8. Impossibility of displacement to the Health Center by themselves.'}, 'identificationModule': {'nctId': 'NCT02331459', 'acronym': 'EMTIFE', 'briefTitle': 'Training Intervention in a Controlled Population of Frail Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de la Ribera'}, 'officialTitle': 'Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.', 'orgStudyIdInfo': {'id': 'HULR-EMTIFE-2013-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Multicomponent training intervention :\n\n3 sessions a week of 45 minutes of resistance activity (24 weeks) 2 sessions a week of 45 minutes of strength training (24 weeks) 5 sessions a week of 15 minutes of proprioceptive training (24 weeks)', 'interventionNames': ['Other: Multicomponent training intervention', 'Other: Nutritional intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Normal routine during 24 weeks.', 'interventionNames': ['Other: Nutritional intervention']}], 'interventions': [{'name': 'Multicomponent training intervention', 'type': 'OTHER', 'description': 'Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)\n\nLegend:\n\nmin. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% maximal Heart rate c = Strength training arms and legs d = Stretching', 'armGroupLabels': ['Intervention group']}, {'name': 'Nutritional intervention', 'type': 'OTHER', 'description': 'Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.\n\nCalcium plus vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) Vitamin D will be provided if calcidiol (Cldl) blood levels are lower than 30 ng/ml.\n\nCldl 20-29 ng/dl it will provide calciferol 20.000 IU every 15 days (3 months) Cldl 10-19 ng/dl it will provide calciferol 20.000 IU every 10 days (3 months) Cldl 1-9 ng/dl it will provide calciferol 20.000 IU every 7 days (3 months)', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46600', 'city': 'Alzira', 'state': 'Valéncia', 'country': 'Spain', 'facility': 'Hospital Universitario de la Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}], 'overallOfficials': [{'name': 'Pilar Pérez-Ros, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Catholic University of Valencia San Vicente Mártir'}, {'name': 'Francisco Martínez-Arnau, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Valencia'}, {'name': 'Jose Vina, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univeristy of Valencia'}, {'name': 'Carmen Gómez-Cabrera, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Valencia'}, {'name': 'Francisco J Tarazona-Santabalbina, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de la Ribera'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de la Ribera', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valencia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Francisco Jose Tarazona-Santabalbina', 'investigatorAffiliation': 'Hospital de la Ribera'}}}}