Effect of Rhythm-based Multitask Training on Falls Among Older Adults (RYMA)
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|ClinicalTrials.gov Identifier: NCT04620421|
Recruitment Status : Suspended (COVID-19)
First Posted : November 9, 2020
Last Update Posted : January 20, 2021
In this assessor-blinded, randomized, controlled trial our primary aim is to quantify the effects of a six-month rhythm-based multitask training (RYMA) intervention on fall rates collected over 12 months, compared to continuation of regular activity schedule, among community-dwelling older adults (≥70 years).
This assessor-blinded, randomized, controlled trial aim is to quantify the effects of six-month rhythm-based multitask training (RYMA) on fall rates collected over 12 months, compared to continuation of regular activity schedule, among community-dwelling older adults (≥70 years).
A sample size calculation estimates that 126 older community-dwelling older adults (≥70 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the RYMA or the control group. The participants in the RYMA group will be assigned to a single weekly one-hour session for six months, while the control group will be encouraged to continue their regular activity schedule. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from the beginning of training using monthly fall calendars. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess circumstances and consequences (e.g. fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological surrogate outcomes will be made at baseline, six, and 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Accidental Fall Fall Injury||Other: Rhythm-based Multitask Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
After baseline assessments, participants will be randomly allocated to either the training or control group. To produce groups of similar size a permuted block randomization will be used. Allocation concealment will be maintained using random block sizes (4, 6, or 8) and by the randomization code only being available for non-blinded research staff.
The intervention group will undergo 6 months of RYMA training, meanwhile, the control group will continue their regular activity schedule.
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The randomization will be conducted by staff members not involved in the data collection. Moreover, the randomization code will only be available for non-blinded research staff to maintain allocation concealment.|
|Official Title:||Effect of Rhythm-based Multitask Training on Fall Rate in Community-dwelling Older Adults: An Assessor-blinded, Randomized, Controlled Trial|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Training group (Rhythm-based multitask training)
Randomized to participate in the rhythm-based multitask training intervention
Other: Rhythm-based Multitask Training
Participants will be assigned to a weekly one-hour RYMA session for six months, followed by a six-month follow-up period without training. An experienced instructor will perform the RYMA sessions, which consists of a wide variety of rhythm-based multitask exercises performed to improvised piano music. The RYMA intervention is inspired by Dalcroze eurhythmics and exercises consists of components such as 1) coordination between hands and/or feet, 2) dissociation between hands and/or feet, 3) movements based on musical cues (e.g. follow the tempo), 4) movement inhibition based on musical cues, 5) handling of props (e.g. balls, scarfs, and plates), 6) pair or group-based coordination movements (e.g. clapping each other's hands and mirroring movements), 7) memorizing and repeating of rhythmic patterns, and 8) quick motoric responses to unexpected cues.
No Intervention: Control group (Continuation of regular activity schedule)
Randomized to the control group who is encouraged to continue their regular everyday routines, which may include self-administrated training exercises.
- Fall rate (falls per person-years) [ Time Frame: 12 months following the randomization ]Fall calendar
- Number of falls, number of fallers/non-/multiple-fallers, and time to first fall [ Time Frame: 12 months following the randomization ]Fall calendar
- Number of fall-related injuries [ Time Frame: 12 months following the randomization ]Fall-calendar, verified by radiologically evidence
- Number of fall-related hospital admissions [ Time Frame: 12 months following the randomization ]Fall-calendar, verified by medical journals
- Single- and dual-task gait [ Time Frame: Baseline, six months, and 12 months ]8-meter gait test; dual-task: Serial subtractions by 3 from an random three-digit number
- Single- and dual-task balance [ Time Frame: Baseline, six months, and 12 months ]30-second static balance; dual-task: Grocery verbal fluency
- Choice stepping reaction time [ Time Frame: Baseline, six months, and 12 months ]Choice stepping reactions test on a Wii balance board
- Lower extremity physical performance [ Time Frame: Baseline, six months, and 12 months ]The Short Physical Performance Battery
- Health-related quality of life [ Time Frame: Baseline, six months, 12 months, and during phone-interview following a registered fall ]The EuroQoL EQ-5D-5L, Danish version
- Fear of Falling [ Time Frame: Baseline, six months, and 12 months ]The Short Falls Efficacy Scale international, Danish version
- Loneliness [ Time Frame: Baseline, six months, and 12 months ]The UCLA Loneliness Scale, Danish version
- Executive function [ Time Frame: Baseline, six months, and 12 months ]The Trail Making task Part A and B
- Frailty [ Time Frame: Baseline and 12 months ]The Tilburg Frailty Indicator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620421
|Department of Geriatric Medicine at Aalborg University|
|Aalborg, Northern Jutland, Denmark, 9000|
|Principal Investigator:||Jens E Nørgaard, Cand.Scient.||Aalborg University Hospital|