danceSing Care Evaluation: Testing the Effectiveness

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601102
• Other study ID #: dC 3735
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: November 2023
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aging
• Depression, Anxiety
• Healthy Aging
• Older Adults
• Quality of Life
• Stress, Physiological

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Holmes Care group	Upminster	Essex

Sponsors (1)

Lead Sponsor	Collaborator
University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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).	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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?".	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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).	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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.	Before and 1 month after completion of the 12-week intervention period.
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)	Before and 1 month after completion of the 12-week intervention period.
Secondary	Acceptability of the intervention assessed by focus groups	The investigators will conduct focus groups with the involved activity coordinators in the care home to assess acceptability.	1 month after completion after the completion of the 12-week intervention period
Secondary	Acceptability of the intervention assessed by interviews	The investigators will conduct interviews with the participants in the care home to assess acceptability.	1 month after completion after the completion of the 12-week intervention period