danceSing Care Evaluation: Testing the Effectiveness

Study Overview
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Brief Summary
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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. The main questions it aims to answer are: Do salivary cortisol and DHEAS levels improve after the intervention, compared to the waitlist control group? Do feelings of anxiety and depression improve after the intervention, compared to the waitlist control group? Does the quality of life improve after the intervention, compared to the waitlist control group? Does physical function improve after the intervention, compared to the waitlist control group? Participants 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.

Official Title
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Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.

Conditions
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Older Adults, Healthy Aging, Aging, Quality of Life, Depression, Anxiety, Stress, Physiological

Intervention / Treatment
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* Behavioral: danceSing Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: residents in care homes ≥ 65 years, able to complete 12 weeks of a movement and music program, 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 Exclusion Criteria: currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study, pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made, inability to adequately understand written/spoken English to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: danceSing Care<br>* - 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.<br>|
| No Intervention: Waitlist control group<br>Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline salivary cortisol levels | 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. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline psychosocial wellbeing using the Hospital Anxiety and Depression Scale (HADS) | 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. | Before and 1 month after completion of the 12-week intervention period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Fear of falling using the Falls Efficacy Scale - International (short form)(FES-I) | 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). | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline Activities of daily living and health-related quality of life using The Dartmouth COOP charts | 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of 1 = no impairment, 5 = most impaired. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline Psychosocial wellbeing using the brief UCLA loneliness scale (ULS-6) | 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?. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline Psychosocial wellbeing using the Perceived Stress Scale (PSS) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline Sleep satisfaction using the National Sleep Foundation's Sleep Satisfaction Tool (SST) | 9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline physical function using the short performance battery | 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). | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline physical function using hand grip strength | 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. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline physical function using Fried frailty phenotype criteria | 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. | Before and 1 month after completion of the 12-week intervention period. | 
| Change from baseline salivary DHEAS levels at 12 weeks | 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) | Before and 1 month after completion of the 12-week intervention period. | 
| Acceptability of the intervention assessed by focus groups | The investigators will conduct focus groups with the involved activity coordinators in the care home to assess acceptability. | 1 month after completion after the completion of the 12-week intervention period | 
| Acceptability of the intervention assessed by interviews | The investigators will conduct interviews with the participants in the care home to assess acceptability. | 1 month after completion after the completion of the 12-week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised controlled trial, clinical trial, music and movement intervention, care home, cortisol, DHEAS