Effect of Rhythm-based Multitask Training on Falls Among Older Adults (RYMA)

Effect of Rhythm-based Multitask Training on Fall Rate in Community-dwelling Older Adults: An Assessor-blinded, Randomized, Controlled Trial

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.

Study Overview

• Status: Suspended
• Conditions: Fall Injury; Accidental Fall
• Intervention / Treatment: Other: Rhythm-based Multitask Training

Detailed Description

Background:

Approximately one-third of older adults (≥65 years) fall at least once a year and 40-60% of falls lead to injuries. Of these injuries, 30-40% are minor, such as brushes, while 10% are serious, such as head injuries or fractures. Indeed, falls are the most common cause of injuries among older adults, and injuries are the fifth leading cause of premature death among older adults.

In an attempt to reduce the fall rate, several fall prevention interventions have been examined. Here, physical exercise has proven as an effective and cost-effective approach. However, the majority of exercise interventions only addressed physical risk factors while only a few focused on cognitive risk factors. For instance, a reduced executive function has been associated with increased fall risk. Thus, interventions addressing both physical and cognitive functions could enhance the efficacy of fall prevention.

Cognitive-motor training is a training modality that simultaneously incorporates physical and cognitive elements. A cognitive-motor training approach is RhYthm-based Multitask trAining (RYMA). During RYMA, participants perform rhythm-based balance-challenging multitask exercises following the rhythm of improvised piano music. A preliminary study by Trombetti et al. 2011 showed promising results as the fall rate decreased by 54% following six months of RYMA using a Dalcroze Eurhythmics approach compared to controls. The observed reduced fall rate may be due to RYMAs ability to decrease gait variability under dual-task conditions, improve postural balance, and executive function. However, the Trombetti study had some limitations. For instance, the primary outcome was gait-variability and not fall rates. Thus, the study was not adequately designed to quantify differences in fall rates (e.g. no follow-up period with a no-attention control group). Moreover, the effects of RYMA on social-psychological factors, such as health-related quality of life (HRQoL), fear of falling, and loneliness is yet be investigated.

Methods:

This assessor-blinded, randomized, controlled trial primarily aims to quantify the effects of a six-month RYMA intervention on fall rates collected over 12 months compared to continuation of regular activity schedule, among community-dwelling older adults (≥70 years). Secondly, we want to evaluate the effects of RYMA on fall risk, fall-related fractures, fall-related hospital admissions, as well as physical, cognitive, and social-psychological factors to explain potential mechanisms concerning fall rate.

Community-dwelling older adults, the municipality of Aalborg will be recruited through appetizers of RYMA, flyers, and advertisements in local newspapers, radio, and television. After baseline assessments, participants will be randomly allocated to either the RYMA or 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., which may include self-administrated training exercises. The primary outcome, fall rate (falls per person-year), will be assessed continuously from the day of the baseline assessments and for 12 months after the RYMA intervention begins using monthly fall calendars in line with the recommendation. In the present study, a fall will be defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower-level". 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. The secondary surrogate outcomes will be assessed at baseline, six, and 12 months. All data will be analyzed using an intention-to-treat approach.

A pilot study will be performed before the commencement of the study to evaluate the feasibility of employing RYMA at the senior activity centres and the acceptance of RYMA and the testing battery among participants. Thus, changes the protocol may be conducted based on the pilot study findings.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Northern Jutland
    • Aalborg, Northern Jutland, Denmark, 9000
      • Department of Geriatric Medicine at Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥70 years old
• Community-dwelling
• Able to walk 20 meters without a walking aid
• Understand and remember a message in Danish
• Willing to provide informed consent for the trial

Exclusion Criteria:

• Having a progressive neurological disease (e.g. Parkinson, multiple sclerosis, etc.)
• Unstable medical conditions that would prevent safe participation
• Severe cognitive impairment
• Current participation in another fall prevention trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall rate (falls per person-years)	Fall calendar	12 months following the randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls, number of fallers/non-/multiple-fallers, and time to first fall	Fall calendar	12 months following the randomization
Number of fall-related injuries	Fall-calendar, verified by radiologically evidence	12 months following the randomization
Number of fall-related hospital admissions	Fall-calendar, verified by medical journals	12 months following the randomization
Single- and dual-task gait	8-meter gait test; dual-task: Serial subtractions by 3 from an random three-digit number	Baseline, six months, and 12 months
Single- and dual-task balance	30-second static balance; dual-task: Grocery verbal fluency	Baseline, six months, and 12 months
Choice stepping reaction time	Choice stepping reactions test on a Wii balance board	Baseline, six months, and 12 months
Lower extremity physical performance	The Short Physical Performance Battery	Baseline, six months, and 12 months
Health-related quality of life	The EuroQoL EQ-5D-5L, Danish version	Baseline, six months, 12 months, and during phone-interview following a registered fall
Fear of Falling	The Short Falls Efficacy Scale international, Danish version	Baseline, six months, and 12 months
Loneliness	The UCLA Loneliness Scale, Danish version	Baseline, six months, and 12 months
Executive function	The Trail Making task Part A and B	Baseline, six months, and 12 months
Frailty	The Tilburg Frailty Indicator	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Jens E Nørgaard, Cand.Scient., Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Older adults; Dual-task; Fall prevention; Gait adaptability; Multitask; Music-based exercise; Dalcroze Eurhythmics
• Other Study ID Numbers: N-20200019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No