danceSing Care Evaluation: Testing the Effectiveness

Keywords

• randomised controlled trial
• clinical trial
• music and movement intervention
• care home
• cortisol
• DHEAS

Lead sponsor

University of Stirling is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Study arms

• 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

• 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/).

Interventions

• BehavioraldanceSing 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.

Primary outcomes

1. 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.

   Time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.

2. 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.

   Time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.

Secondary outcomes

1. 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).

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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).

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

7. 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.

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

8. 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.

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

9. 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)

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

10. 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.

    Time frame: 1 month after completion after the completion of the 12-week intervention period

Other outcomes

1. Acceptability of the Intervention

   Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis

   Time frame: 12weeks

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Nov 19, 2021
• Informed consent form · Sep 28, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No