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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Waitlist control group | No Intervention | Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danceSing Care | Behavioral | - 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. |
| 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. | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of 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. The range of scores for each of the two subscales (anxiety and depression) is 0-21, respectively. | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Intervention | Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis | 12weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Whittaker&, PhD | University of Stirling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holmes Care group | Upminster | Essex | RM14 3DH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39232667 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group n = 17 | 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. danceSing 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. |
| FG001 | Waitlist Control Group n = 17 | Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
n = 34 randomised into groups for the intervention, n = 27 combined participants at follow-up. Older adults in residential care homes aged 65+ years.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group n = 17 | 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. danceSing 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | combined intervention and waitlist group who consented to saliva sampling | Posted | Mean | 95% Confidence Interval | micrograms per deciliter | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period. |
|
12 weeks of pilot trial
Death or serious fall resulting in hospitalisation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group n = 17 | 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. danceSing 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Anna C. Whittaker | University of Stirling | 0178646 | 7816 | a.c.whittaker@stir.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2021 | Aug 13, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2022 | Oct 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
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| 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?" 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. | 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 Interviews | 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. | 1 month after completion after the completion of the 12-week intervention period |
| Lost to Follow-up |
|
| BG001 | Waitlist Control Group n = 17 | Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
|
| Primary | 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. The range of scores for each of the two subscales (anxiety and depression) is 0-21, respectively. | intervention and waitlist groups combined - anxiety subscale | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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). | intervention and waitlist groups combined | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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. | intervention and waitlist groups combined | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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?" 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. | intervention and waitlist groups combined | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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. | intervention and waitlist groups combined | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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. | intervention and waitlist groups combined | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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). | intervention and waitlist groups combined who consented to physical function measures | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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. | intervention and waitlist groups combined who consented to physical function | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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. | intervention and waitlist groups combined who consented to physical function testing | Posted | Mean | 95% Confidence Interval | units on a scale | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | 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) | intervention and waitlist groups combined who consented to saliva sampling | Posted | Mean | 95% Confidence Interval | picograms per millilitre | Before and 1 month after completion of the 12-week intervention period. |
|
|
|
|
| Secondary | Acceptability of the Intervention Assessed by Interviews | 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. | 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. | Posted | Count of Participants | Participants | 1 month after completion after the completion of the 12-week intervention period |
|
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| Other Pre-specified | Acceptability of the Intervention | Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis | 12 older adults | Posted | Number | participants | 12weeks |
|
|
|
| 1 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Waitlist Control Group n = 17 | Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/). | 2 | 17 | 0 | 17 | 0 | 17 |
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| .42 |
| Equivalence |
pre- to post-intervention paired t-test, two-tailed |
| Title | Measurements |
|---|---|
|