Aging, Depression, Anxiety, Healthy Aging, Older Adults, Quality of Life, Stress, Physiological
Conditions
Keywords
randomised controlled trial, clinical trial, music and movement intervention, care home, cortisol, DHEAS
Brief summary
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.
Interventions
BEHAVIORALdanceSing 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.
Sponsors
University of Stirling
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS) | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period. | 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. |
| Change From Baseline Salivary Cortisol Levels | Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts | Before and 1 month after completion of the 12-week intervention period. | 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of 1 = no impairment, 5 = most impaired. |
| Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6) | Before and 1 month after completion of the 12-week intervention period. | 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. |
| Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS) | Before and 1 month after completion of the 12-week intervention period. | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. |
| Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST) | Before and 1 month after completion of the 12-week intervention period. | 9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction. |
| Change From Baseline Physical Function Using Hand Grip Strength | Before and 1 month after completion of the 12-week intervention period. | 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. |
| Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria | Before and 1 month after completion of the 12-week intervention period. | 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. |
| Change From Baseline Salivary DHEAS Levels at 12 Weeks | Before and 1 month after completion of the 12-week intervention period. | 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) |
| Acceptability of the Intervention Assessed by Interviews | 1 month after completion after the completion of the 12-week intervention period | 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. |
| Change From Baseline Physical Function Using the Short Performance Battery | Before and 1 month after completion of the 12-week intervention period. | 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). |
| Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I) | Before and 1 month after completion of the 12-week intervention period. | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Intervention | 12weeks | Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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/). | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention Group n = 17 | Waitlist Control Group n = 17 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 65-74 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized 75-84 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Customized 85+ years | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 17 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 17 | 2 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
Population: intervention and waitlist groups combined - anxiety subscale
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS) | Anxiety | 1.5 units on a scale |
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS) | Depression | .41 units on a scale |
Comparison: Anxiety subscale analysisp-value: 0.01t-test, 2 sided
Comparison: Depression subscalep-value: 0.42t-test, 2 sided
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.
Time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
Population: combined intervention and waitlist group who consented to saliva sampling
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Salivary Cortisol Levels | -0.1 micrograms per deciliter |
p-value: 0.41t-test, 2 sided
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.
Time frame: 1 month after completion after the completion of the 12-week intervention period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Acceptability of the Intervention Assessed by Interviews | Intervention Fidelity | 12 Participants |
| Combined Intervention and Waitlist Control Group Pre-post- | Acceptability of the Intervention Assessed by Interviews | Attendance | 12 Participants |
| Combined Intervention and Waitlist Control Group Pre-post- | Acceptability of the Intervention Assessed by Interviews | Retention | 12 Participants |
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts | 1.12 units on a scale |
p-value: 0.15t-test, 2 sided
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).
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I) | 1.82 units on a scale |
p-value: 0.04t-test, 2 sided
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined who consented to physical function testing
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria | 0 units on a scale |
p-value: 1t-test, 2 sided
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined who consented to physical function
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Physical Function Using Hand Grip Strength | -.27 units on a scale |
p-value: 0.6t-test, 2 sided
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).
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined who consented to physical function measures
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Physical Function Using the Short Performance Battery | 0 units on a scale |
p-value: 1t-test, 2 sided
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6) | 1.64 units on a scale |
p-value: 0.02t-test, 2 sided
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS) | 1.38 units on a scale |
p-value: 0.22t-test, 2 sided
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)
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined who consented to saliva sampling
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Salivary DHEAS Levels at 12 Weeks | -903.81 picograms per millilitre |
p-value: <0.001t-test, 2 sided
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.
Time frame: Before and 1 month after completion of the 12-week intervention period.
Population: intervention and waitlist groups combined
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST) | -.96 units on a scale |
p-value: 0.29t-test, 2 sided
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
Time frame: 12weeks
Population: 12 older adults
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Intervention and Waitlist Control Group Pre-post- | Acceptability of the Intervention | 12 participants |