NCT05601102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

October 24, 2022

Results QC Date

December 3, 2024

Last Update Submit

May 6, 2025

Conditions

Keywords

randomised controlled trialclinical trialmusic and movement interventioncare homecortisolDHEAS

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (10)

  • 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.

  • 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.

  • 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.

  • Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)

    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)

    Before and 1 month after completion of the 12-week intervention period.

  • +5 more secondary outcomes

Other Outcomes (1)

  • Acceptability of the Intervention

    12weeks

Study Arms (2)

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.

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/).

Interventions

danceSing CareBEHAVIORAL

\- 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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holmes Care group

Upminster, Essex, RM14 3DH, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Professor Anna C. Whittaker
Organization
University of Stirling

Study Officials

  • Anna Whittaker&, PhD

    University of Stirling

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicentre Randomized (1:1), waitlist Controlled, parallel-group Trial (RCT).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 1, 2022

Study Start

March 20, 2023

Primary Completion

June 20, 2023

Study Completion

August 20, 2023

Last Updated

May 20, 2025

Results First Posted

February 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations