Holmes Care group
Upminster, Essex, RM14 3DH, United Kingdom
NCT Number: NCT05601102
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.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Upminster, Essex, RM14 3DH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
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.
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: Before and 1 month after completion of the 12-week intervention period.
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.
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.
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.
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.
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.
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.
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.
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.
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: 1 month after completion after the completion of the 12-week intervention period
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: 12weeks
Acceptability of the intervention as assessed by focus groups and semi-structured interviews - qualitative data collection and thematic analysis
University of Stirling
Other
Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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