Clinical trial NCT05601102: danceSing Care Evaluation: Testing the Effectiveness
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Stirling
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change From Baseline Salivary Cortisol Levels
timeFrame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
measure: Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
Secondary outcomes:
measure: Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6)
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Physical Function Using the Short Performance Battery
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Physical Function Using Hand Grip Strength
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Change From Baseline Salivary DHEAS Levels at 12 Weeks
timeFrame: Before and 1 month after completion of the 12-week intervention period.
measure: Acceptability of the Intervention Assessed by Interviews
timeFrame: 1 month after completion after the completion of the 12-week intervention period
Other outcomes:
measure: Acceptability of the Intervention
timeFrame: 12weeks
Locations:
city: Upminster
country: United Kingdom
facility: Holmes Care group
state: Essex
Study officials:
affiliation: University of Stirling
name: Anna Whittaker&, PhD
role: PRINCIPAL_INVESTIGATOR
References: