Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05601102
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
danceSing Care Evaluation: Testing the Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.c.whittaker@stir.ac.uk', 'phone': '0178646', 'title': 'Professor Anna C. Whittaker', 'phoneExt': '7816', 'organization': 'University of Stirling'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks of pilot trial', 'description': 'Death or serious fall resulting in hospitalisation', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group n = 17', 'description': 'The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of two movement sessions and one music session each week, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.\n\ndanceSing Care: - Physical activity interventions, including multi-component (chair-based) exercises or dancing, and music therapies have been shown to improve multidimensional health markers in older adults.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Waitlist Control Group n = 17', 'description': 'Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Salivary Cortisol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-.34', 'upperLimit': '.15'}]}]}], 'analyses': [{'pValue': '.41', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.', 'description': 'Saliva samples will be obtained to determine free salivary cortisol. If the test is done around 9 AM, the results would be between 100 and 750 ng/dL. Any dysregulation, notably higher cortisol levels, may indicate poor health outcomes.', 'unitOfMeasure': 'micrograms per deciliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'combined intervention and waitlist group who consented to saliva sampling'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '.4', 'upperLimit': '2.60'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '.41', 'groupId': 'OG000', 'lowerLimit': '-.62', 'upperLimit': '1.44'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000'], 'groupDescription': 'Anxiety subscale analysis', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}, {'pValue': '.42', 'groupIds': ['OG000'], 'groupDescription': 'Depression subscale', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.', 'description': 'The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. The range of scores for each of the two subscales (anxiety and depression) is 0-21, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined - anxiety subscale'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '.07', 'upperLimit': '3.58'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '-.41', 'upperLimit': '2.64'}]}]}], 'analyses': [{'pValue': '.15', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': '5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '.30', 'upperLimit': '2.97'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Using a 4-point rating scale (1= never; 4 = always), participants answer 6 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" The rating given in answer to each of the questions are summed to form a total score. Thus the range of scores for the total is 6 to 24. A higher score is worse loneliness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '-.84', 'upperLimit': '3.61'}]}]}], 'analyses': [{'pValue': '.22', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined'}, {'type': 'SECONDARY', 'title': "Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.96', 'groupId': 'OG000', 'lowerLimit': '-2.79', 'upperLimit': '.86'}]}]}], 'analyses': [{'pValue': '.29', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': "9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Physical Function Using the Short Performance Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-.73', 'upperLimit': '.73'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'The Short Physical Performance Battery (SPPB) is a relatively simple test that can provide insight into walking speed, balance and leg strength, important factors for self-reliance, in a short period of time. The SPPB is increasingly used in the scientific literature as an outcome measure for mobility and a predictor of health outcomes. The test consists of three tests: a walking test, a balance test and a repeated chair-stand test. The scores range from 0 (worst performance) to 12 (best performance).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined who consented to physical function measures'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Physical Function Using Hand Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.27', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '.76'}]}]}], 'analyses': [{'pValue': '.60', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles, and is suggested to be a marker of health and longevity. Reported hand grip strengths markers: 41.7 and 25.9 kg, respectively, in men and women aged 60-64 years, 41.7 and 25.6 kg for ages 65-69 years, 38.2 and 24.2 kg for ages 70-74 years, and 28 and 18.0 kg for age \\>75 years, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined who consented to physical function'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-.2', 'upperLimit': '.2'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': "The Fried's frailty phenotype defines frailty as the presence of five components: weakness, slowness, exhaustion, low physical activity, and unintentional weight loss. Scoring: ≥3/5 criteria met indicates frailty; 1-2/5 indicates pre-or-intermediate frailty; 0/5 indicates non-frail.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined who consented to physical function testing'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Salivary DHEAS Levels at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '-903.81', 'groupId': 'OG000', 'lowerLimit': '-1267.26', 'upperLimit': '-540.36'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'pre- to post-intervention paired t-test, two-tailed'}], 'paramType': 'MEAN', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Saliva samples will be obtained to determine DHEAS. Any dysregulation, notably lower DHEAS levels, may indicate poor health outcomes. (Average levels: ages 60 to 69: 13 to 130 µg/dL or 0.35 to 3.51 µmol/L Ages 69 and older: 17 to 90 µg/dL or 0.46 to 2.43 µmol/L)', 'unitOfMeasure': 'picograms per millilitre', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intervention and waitlist groups combined who consented to saliva sampling'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Intervention Assessed by Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Intervention and Waitlist Control Group Pre-post-', 'description': 'The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.'}], 'classes': [{'title': 'Intervention Fidelity', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Attendance', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Retention', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'The researchers devised the semi-structured interview guide in consultation with the study advisory group and focused on the overview of what participants and activity coordinators thought of the programme, acceptability of the intervention and any benefits they derived, or barriers experienced. Thematic analysis by independent researchers was deductive, focusing on the progression criteria identified as key feasibility outcomes. Themes were then coded from the keywords and phrases found to be consistent throughout the interviews. Themes labelling was mostly in line with components of the progression criteria hence: Fidelity, Attendance and Retention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 randomly sampled older adults/activity coordinators from across 4 homes. A subsample of seven participants was interviewed two weeks after completing the post-intervention measures to explore additional in-depth intervention effects not captured in the survey, biological, and physical function testing measures. Five care home staff (activity coordinators and/or carers) who facilitated the online intervention were also interviewed in person to share their experiences throughout the process.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': '12 interviews across 4 homes who ran the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12weeks', 'description': 'Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 older adults'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group n = 17', 'description': 'The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of two movement sessions and one music session each week, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.\n\ndanceSing Care: - Physical activity interventions, including multi-component (chair-based) exercises or dancing, and music therapies have been shown to improve multidimensional health markers in older adults.'}, {'id': 'FG001', 'title': 'Waitlist Control Group n = 17', 'description': 'Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'comment': 'Unfortunately, the randomised waitlist control group design was not adhered to. As the interventions took place in the communal living rooms where the waitlist-control group was also present, this group at times, also received the intervention.', 'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Intervention and control group were combined for pre- to post-intervention analysis rather than group comparison.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group n = 17', 'description': 'The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of two movement sessions and one music session each week, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.\n\ndanceSing Care: - Physical activity interventions, including multi-component (chair-based) exercises or dancing, and music therapies have been shown to improve multidimensional health markers in older adults.'}, {'id': 'BG001', 'title': 'Waitlist Control Group n = 17', 'description': 'Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '65-74 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '75-84 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '85+ years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'n = 34 randomised into groups for the intervention, n = 27 combined participants at follow-up. Older adults in residential care homes aged 65+ years.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-19', 'size': 713592, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-13T06:49', 'hasProtocol': True}, {'date': '2022-09-28', 'size': 179081, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-24T07:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-10-24', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-28', 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability of the Intervention', 'timeFrame': '12weeks', 'description': 'Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis'}], 'primaryOutcomes': [{'measure': 'Change From Baseline Salivary Cortisol Levels', 'timeFrame': 'Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.', 'description': 'Saliva samples will be obtained to determine free salivary cortisol. If the test is done around 9 AM, the results would be between 100 and 750 ng/dL. Any dysregulation, notably higher cortisol levels, may indicate poor health outcomes.'}, {'measure': 'Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.', 'description': 'The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. The range of scores for each of the two subscales (anxiety and depression) is 0-21, respectively.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).'}, {'measure': 'Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': '5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.'}, {'measure': 'Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6)', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Using a 4-point rating scale (1= never; 4 = always), participants answer 6 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" The rating given in answer to each of the questions are summed to form a total score. Thus the range of scores for the total is 6 to 24. A higher score is worse loneliness.'}, {'measure': 'Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.'}, {'measure': "Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)", 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': "9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction."}, {'measure': 'Change From Baseline Physical Function Using the Short Performance Battery', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'The Short Physical Performance Battery (SPPB) is a relatively simple test that can provide insight into walking speed, balance and leg strength, important factors for self-reliance, in a short period of time. The SPPB is increasingly used in the scientific literature as an outcome measure for mobility and a predictor of health outcomes. The test consists of three tests: a walking test, a balance test and a repeated chair-stand test. The scores range from 0 (worst performance) to 12 (best performance).'}, {'measure': 'Change From Baseline Physical Function Using Hand Grip Strength', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles, and is suggested to be a marker of health and longevity. Reported hand grip strengths markers: 41.7 and 25.9 kg, respectively, in men and women aged 60-64 years, 41.7 and 25.6 kg for ages 65-69 years, 38.2 and 24.2 kg for ages 70-74 years, and 28 and 18.0 kg for age \\>75 years, respectively.'}, {'measure': 'Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': "The Fried's frailty phenotype defines frailty as the presence of five components: weakness, slowness, exhaustion, low physical activity, and unintentional weight loss. Scoring: ≥3/5 criteria met indicates frailty; 1-2/5 indicates pre-or-intermediate frailty; 0/5 indicates non-frail."}, {'measure': 'Change From Baseline Salivary DHEAS Levels at 12 Weeks', 'timeFrame': 'Before and 1 month after completion of the 12-week intervention period.', 'description': 'Saliva samples will be obtained to determine DHEAS. Any dysregulation, notably lower DHEAS levels, may indicate poor health outcomes. (Average levels: ages 60 to 69: 13 to 130 µg/dL or 0.35 to 3.51 µmol/L Ages 69 and older: 17 to 90 µg/dL or 0.46 to 2.43 µmol/L)'}, {'measure': 'Acceptability of the Intervention Assessed by Interviews', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'The researchers devised the semi-structured interview guide in consultation with the study advisory group and focused on the overview of what participants and activity coordinators thought of the programme, acceptability of the intervention and any benefits they derived, or barriers experienced. Thematic analysis by independent researchers was deductive, focusing on the progression criteria identified as key feasibility outcomes. Themes were then coded from the keywords and phrases found to be consistent throughout the interviews. Themes labelling was mostly in line with components of the progression criteria hence: Fidelity, Attendance and Retention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomised controlled trial', 'clinical trial', 'music and movement intervention', 'care home', 'cortisol', 'DHEAS'], 'conditions': ['Older Adults', 'Healthy Aging', 'Aging', 'Quality of Life', 'Depression, Anxiety', 'Stress, Physiological']}, 'referencesModule': {'references': [{'pmid': '39232667', 'type': 'DERIVED', 'citation': 'De Nys L, Oyebola EF, Connelly J, Ryde GC, Whittaker AC. Digital music and movement intervention to improve health and wellbeing in older adults in care homes: a pilot mixed methods study. BMC Geriatr. 2024 Sep 4;24(1):733. doi: 10.1186/s12877-024-05324-3.'}]}, 'descriptionModule': {'briefSummary': 'This pilot randomised controlled trial aims to compare the effectiveness of a 12-week music and movement intervention in older adults in care homes compared to a waitlist control group.\n\nThe main questions it aims to answer are:\n\n* Do salivary cortisol and DHEAS levels improve after the intervention, compared to the waitlist control group?\n* Do feelings of anxiety and depression improve after the intervention, compared to the waitlist control group?\n* Does the quality of life improve after the intervention, compared to the waitlist control group?\n* Does physical function improve after the intervention, compared to the waitlist control group?\n\nParticipants will engage in music and movement sessions three times per week for 12 weeks. Researchers will compare the intervention group to the waitlist control group to see if any effects occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in care homes ≥ 65 years,\n* able to complete 12 weeks of a movement and music program,\n* having the capacity to give informed consent as assessed by care staff and confirmed in discussion about the project with the research team using the British Psychological Society capacity checklist\n\nExclusion Criteria:\n\n* currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study,\n* pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made,\n* inability to adequately understand written/spoken English to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).'}, 'identificationModule': {'nctId': 'NCT05601102', 'briefTitle': 'danceSing Care Evaluation: Testing the Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'University of Stirling'}, 'officialTitle': 'Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'dC 3735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of two movement sessions and one music session each week, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.', 'interventionNames': ['Behavioral: danceSing Care']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).'}], 'interventions': [{'name': 'danceSing Care', 'type': 'BEHAVIORAL', 'description': '\\- Physical activity interventions, including multi-component (chair-based) exercises or dancing, and music therapies have been shown to improve multidimensional health markers in older adults.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RM14 3DH', 'city': 'Upminster', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Holmes Care group', 'geoPoint': {'lat': 51.55594, 'lon': 0.2556}}], 'overallOfficials': [{'name': 'Anna Whittaker&, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Stirling'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Stirling', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Whittaker', 'investigatorAffiliation': 'University of Stirling'}}}}