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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05203848
Other study ID # NUS-IRB-2020-808
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 9, 2021
Est. completion date March 31, 2022

Study information

Verified date January 2022
Source National University, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: The primary objective of the proposed project is to develop and evaluate a Community Dance Program (CDP) for community-dwelling older adults, which is aimed at promoting physical strength, balance, cognition, mental and psycho-social well-being of the older adults. A distinctive feature of our project is that a team of researchers across disciplines and community partners will collaborate to develop the program and bring benefits to the older adults living in the community.


Description:

Research Design: The research design consists of: (1) Development and implementation of CDP. A pilot cluster randomized controlled trial (RCT) will be conducted to assess the feasibility and primary effect of the program in enhancing the physical, mental, cognitive, and psycho-social health, quality of life, and social support among older adults. (2) Process Evaluation, follow-up focus group discussions will be conducted to assess the acceptability, strengths and limitations of CDP based on the participants' perspectives. Data Collection and Analysis: A set of questionnaires will be administered to the older adults. The data will be collected at two time points: baseline and 8-week follow-up. Descriptive statistics, Paired sample t-test, Analysis of Covariance (ANCOVA) will be used to examine the difference between the baseline and post-intervention to compare outcome measures from pre to post-implementation. The audio-recorded focused group discussion will be transcribed verbatim respectively. Thematic analysis will be applied to provide an in-depth and rich analysis of the verbatim. Potential Impact: CDP will make a positive impact on the older adults' physical, mental and psychological wellbeing. Those impacts will then encourage older adults to live an active life and maximize their social capital within the community. Therefore, CDP promotes the health and wellbeing of the community-dwelling older adults and reduces geriatric-related conditions. The outcome of the study will have tremendous potential to be implemented at a larger scale in the community. Upon completion of the project, the investigators will work closely with community centres and senior activity centres to integrate CDP into their existing programs. CDP could then benefit a larger population given the evidence gathered from this research to enhance the physical, mental and psychological wellbeing of the older adults.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 59
Est. completion date March 31, 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: - Aged 55 to 85 - Able to understand and communicate in either English or Mandarin - Able to give consent to participate (have sufficient mental capacity as assessed by the MoCA, with a score of 16 and above) - Lives within the community setting - Able to ambulate with minimal assistance - Able to commit a total of 8 hours over the 8-week period dancing program Exclusion Criteria: - Medical conditions which result in limitation of dancing - Older adults with compromised balance and mobility (those who obtained a score of < 5 on the Short Physical Performance Battery (SPPB) - Severe cognitive or psychiatric disorders - Severe hearing or vision impairments - Older adults from the control group who also participate in any other dance group during the intervention period - Older adults who are uncomfortable with video-recording of the dance sessions

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Community Dance Intervention
The main dance instructor for the CDP is Yarra Ileto, who is the Artistic Director for NUS Dance Synergy. Yarra was trained at LASALLE College of the Arts, graduating with a First Class BA (Hons) Dance in 2008. Also, she has experience with crafting and conducting Community Dance Programs (CDP) for Seniors. Yarra will be developing the dance lesson plan and also training selected students from NUS Dance Synergy to guide the seniors during the dance sessions. Older adults will learn and practice the basic steps together for the first few weeks. Then, the student dance instructors will start teaching the dance formation. During each session, participants will need to warm up first to prevent injuries before practicing dance steps. Small group practicing is reserved for older adults to interact with each other. All the participants will do relaxation exercises before ending the session to cool down their bodies and release muscle tensions.
Other:
Control group
Control group

Locations

Country Name City State
Singapore National University of Singapore Singapore

Sponsors (2)

Lead Sponsor Collaborator
National University, Singapore Lion Befrienders

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical health: Blood pressure Blood pressure readings will be measured in units of millimeters of mercury (mmHg). Both systolic and diastolic blood pressure values will be recorded before versus after the research intervention to investigate for any significant changes. 3 months
Primary Physical health: Body Mass Index (BMI) BMI was obtained from each participant by measuring his/her height in units of meters and weight in units of kilograms, followed by this formula: kg/m^2. BMI values will be recorded before versus after the research intervention to investigate for any significant changes. 3 months
Primary Physical health: Waist and hip circumferences Waist and hip circumferences of each participant will be obtained in units of centimeters (cm). These values will be recorded before versus after the research intervention to investigate for any significant changes. 3 months
Primary Physical health: Short Physical Performance Battery (SPPB) SPPB is a comprehensive instrument that can be used to measure balance, mobility, and muscle strength in older adults. It consists of balance tests (i.e., side-by-side stand, semi-tandem stand, tandem stand), gait speed tests, and chair stand tests. All values will be recorded in units of seconds and consolidated into the corresponding sum of scores upon successful completion of each test. Higher SPPB scores indicate greater physical capabilities. 3 months
Primary Mental health: Subjective Happiness Scale Subjective Happiness Scale using a "subjectivist" approach to the assessment of happiness, a 4-item measure of global subjective happiness was developed and validated in 14 studies with a total of 2732 participants (Lyubomirsky & Lepper,1999). A 7-point Likert scale (1 = less happy to 7 = more happy) was used, with higher scores indicating higher subjective happiness. 3 months
Primary Cognitive health: Montreal Cognitive Assessment (MoCA) MoCA was designed as a screening instrument for mild cognitive dysfunction. It assesses various cognitive domains including attention, concentration, executive function, memory, language, visuospatial, and arithmetic skills. The total possible score is 30 points, with the cutoff score of this research study being 16 points. Participants who scored below 16 points will not be included in the research study. A lower MoCA score indicates greater cognitive dysfunction. 3 months
Primary Cognitive health: Symbol Digit Modalities Test (SDMT) SDMT is a screening measure for cerebral dysfunction in adults. A coding key is presented consisting of nine abstract symbols, each paired with a number. The participant is required to scan through the coding key and write down the number corresponding to each symbol, as rapidly as possible. The number of correct answers within the 90-second interval is recorded. The maximum score is 110, with lower scores suggesting cerebral dysfunction. 3 months
Primary Cognitive health: The Washington University Dementia Screening Test (AD8) This scale is also known as "Eight-item Interview to Differentiate Aging and Dementia". The participant was asked to rate changes in his/her ability for each of the items, without attributing causability. The final score is computed by consolidating the sum of the items marked with a change due to cognitive problems, with higher scores indicating higher impairment in cognition. 3 months
Primary Quality of Life WHOQOL-AGE is a self-reported questionnaire that was designed specifically to measure quality of life (QoL) in the older adult population (Caballero et al., 2013). It consists of 13 items which are selected from the other versions of WHOQOL instruments (5 items from WHOQOL-OLD and 8 items from EUROHIS-QOL). The items were assessed on a five-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores suggesting higher QoL. WHOQOL-AGE has been evaluated and has shown good reliability and validity (Santos et al., 2018). 3 months
Secondary Intergenerational communication Global Perceptions of Intergenerational Communication Scale (GPIC) was developed by McCann & Giles (2007) to measure perceptions of intergenerational communicative experiences. It consists of 25 items rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). The first 14 items of the scale assess perceptions of others' communication while the remaining 11 items assess perceptions of one's own communication. 3 months
Secondary Social support Social Support Questionnaire 6 items (SSQ6) was developed by Sarason and colleagues (Sarason, Sarason, Shearin & Pierce,1987). It is used to measure the number of person providing support to an individual and the satisfaction level of the individual who received the support. The scale consists of 6 items. Rating of the items is from 1 (very dissatisfied) to 6 (very satisfied). With excellent Cronbach alphas of 0.90 and 0.93 for 2 respective domains, the scale has been proved to be valid and reliable. 3 months
Secondary Sociodemographic data Social-demographic data including age, gender, ethnicity, religion, marital status, employment status, education, social-economic status, source of financial support, household type/ownership, living arrangement and number of children will be collected. 3 months
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