danceSing Care Evaluation: Testing the Effectiveness

Sponsor

University of Stirling (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05601102

Collaborator

(none)

Enrollment

Arms

3.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Older Adults Healthy Aging Aging Quality of Life Depression, Anxiety Stress, Physiological	Behavioral: danceSing Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention group

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

- 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.

No Intervention: Waitlist control group

Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).

Outcome Measures

Primary Outcome Measures

Change from baseline salivary cortisol levels [Before and 1 month after 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) [Before and 1 month after 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.

Secondary Outcome Measures

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).
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?".
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 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 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 focus groups [1 month after completion after the completion of the 12-week intervention period]
The investigators will conduct focus groups with the involved activity coordinators in the care home to assess acceptability.
Acceptability of the intervention assessed by interviews [1 month after completion after the completion of the 12-week intervention period]
The investigators will conduct interviews with the participants in the care home to assess acceptability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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).