Trial Outcomes & Findings for danceSing Care Evaluation: Testing the Effectiveness (NCT NCT05601102)

NCT ID: NCT05601102

Last Updated: 2025-05-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
• Results posted on: 2025-05-20

Participant Flow

Participant milestones

Measure	Intervention Group n = 17 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. 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.	Waitlist Control Group n = 17 Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).
Overall Study STARTED	17	17
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Intervention Group n = 17 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. 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.	Waitlist Control Group n = 17 Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).
Overall Study Death	1	2
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

danceSing Care Evaluation: Testing the Effectiveness

Baseline characteristics by cohort

Measure	Intervention Group n = 17 n=17 Participants 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. 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.	Waitlist Control Group n = 17 n=17 Participants Waitlist for 12 weeks before participating in the digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/).	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Customized 65-74 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Customized 75-84 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized 85+ years	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

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

Population: combined intervention and waitlist group who consented to saliva sampling

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=18 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Salivary Cortisol Levels	-0.1 micrograms per deciliter Interval -0.34 to 0.15

PRIMARY outcome

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

Population: intervention and waitlist groups combined - anxiety subscale

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS) Anxiety	1.5 units on a scale Interval 0.4 to 2.6
Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS) Depression	.41 units on a scale Interval -0.62 to 1.44

SECONDARY outcome

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

Population: intervention and waitlist groups combined

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).

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)	1.82 units on a scale Interval 0.07 to 3.58

SECONDARY outcome

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

Population: intervention and waitlist groups combined

5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts	1.12 units on a scale Interval -0.41 to 2.64

SECONDARY outcome

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

Population: intervention and waitlist groups combined

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6)	1.64 units on a scale Interval 0.3 to 2.97

SECONDARY outcome

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

Population: intervention and waitlist groups combined

Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)	1.38 units on a scale Interval -0.84 to 3.61

SECONDARY outcome

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

Population: intervention and waitlist groups combined

9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=34 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)	-.96 units on a scale Interval -2.79 to 0.86

SECONDARY outcome

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

Population: intervention and waitlist groups combined who consented to physical function measures

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).

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=30 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Physical Function Using the Short Performance Battery	0 units on a scale Interval -0.73 to 0.73

SECONDARY outcome

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

Population: intervention and waitlist groups combined who consented to physical function

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=30 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Physical Function Using Hand Grip Strength	-.27 units on a scale Interval -1.3 to 0.76

SECONDARY outcome

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

Population: intervention and waitlist groups combined who consented to physical function testing

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=30 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria	0 units on a scale Interval -0.2 to 0.2

SECONDARY outcome

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

Population: intervention and waitlist groups combined who consented to saliva sampling

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)

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=18 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Change From Baseline Salivary DHEAS Levels at 12 Weeks	-903.81 picograms per millilitre Interval -1267.26 to -540.36

SECONDARY outcome

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

Population: 12 randomly sampled older adults/activity coordinators from across 4 homes. A subsample of seven participants was interviewed two weeks after completing the post-intervention measures to explore additional in-depth intervention effects not captured in the survey, biological, and physical function testing measures. Five care home staff (activity coordinators and/or carers) who facilitated the online intervention were also interviewed in person to share their experiences throughout the process.

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.

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=12 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Acceptability of the Intervention Assessed by Interviews Intervention Fidelity	12 Participants
Acceptability of the Intervention Assessed by Interviews Attendance	12 Participants
Acceptability of the Intervention Assessed by Interviews Retention	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12weeks

Population: 12 older adults

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

Outcome measures

Measure	Combined Intervention and Waitlist Control Group Pre-post- n=12 Participants The waitlist control condition was not adhered to. The control group received the intervention at the same time. Analyses are therefore pre- to post-intervention change across all participants.
Acceptability of the Intervention	12 participants

Adverse Events

Intervention Group n = 17

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Waitlist Control Group n = 17

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Anna C. Whittaker

University of Stirling

Phone: 0178646

Email: a.c.whittaker@stir.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place