Older AdultsNCT05601102
danceSing Care Evaluation: Testing the Effectiveness
A study testing danceSing Care in people with Older Adults and Healthy Aging, run by University of Stirling at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Healthy Aging, Aging
- What is being tested?
- danceSing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2023to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.
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:
Read more
- 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.
- Conditions
- Older Adults, Healthy Aging, Aging, Quality of Life, Depression, Anxiety, Stress, Physiological
- Being tested
- danceSing Care
- Keywords
- randomised controlled trial, clinical trial, music and movement intervention, care home, cortisol, DHEAS
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danceSing CareBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: danceSing Care |
| 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/). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
Secondary outcomes (10)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1 month after completion after the completion of the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start20 Mar 2023
- Primary completion20 Jun 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Whittaker, University of Stirling
- Investigators
- Anna Whittaker&, PhD, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601102
- Sponsor's protocol ID
- dC 3735
- Status last verified
- May 2025
- First submitted
- 24 Oct 2022
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39232667
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05601102
- Acronym / sponsor ID
- dC 3735
- Conditions
- Older Adults, Healthy Aging, Aging, Quality of Life, Depression, Anxiety, Stress, Physiological
- Keywords
- randomised controlled trial, clinical trial, music and movement intervention, care home, cortisol, DHEAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: danceSing CareThe 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/). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Change From Baseline Salivary Cortisol Levels
Time frame: 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.
Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: 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.
10 secondary outcomes
Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)
Time frame: 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
Time frame: 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)
Time frame: Before and 1 month after completion of the 12-week intervention period.
Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)
Time frame: 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)
Time frame: Before and 1 month after completion of the 12-week intervention period.
Change From Baseline Physical Function Using the Short Performance Battery
Time frame: Before and 1 month after completion of the 12-week intervention period.
Change From Baseline Physical Function Using Hand Grip Strength
Time frame: Before and 1 month after completion of the 12-week intervention period.
Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria
Time frame: Before and 1 month after completion of the 12-week intervention period.
Change From Baseline Salivary DHEAS Levels at 12 Weeks
Time frame: Before and 1 month after completion of the 12-week intervention period.
Acceptability of the Intervention Assessed by Interviews
Time frame: 1 month after completion after the completion of the 12-week intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39232667De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Whittaker&, PhD principal investigator
University of Stirling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing danceSing Care in people with Older Adults and Healthy Aging, run by University of Stirling at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Salivary Cortisol Levels (time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.