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

NCT04620421 | Suspended

• 1 other identifier: N-20200019
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Accidental Fall; Fall Injury

Keywords

Older adults; Dual-task; Gait adaptability; Multitask; Music-based exercise; Fall prevention; Exercise; Quality of Life; Dalcroze Eurhythmics

Outcome Measures

Primary Outcomes (1)

• Fall rate (falls per person-years)

  Fall calendar

  12 months following the randomization

Secondary Outcomes (12)

• Number of falls, number of fallers/non-/multiple-fallers, and time to first fall

  12 months following the randomization

• Number of fall-related injuries

  12 months following the randomization

• Number of fall-related hospital admissions

  12 months following the randomization

• Single- and dual-task gait

  Baseline, six months, and 12 months

• Single- and dual-task balance

  Baseline, six months, and 12 months

Study Arms (2)

Training group (Rhythm-based multitask training)

EXPERIMENTAL

Randomized to participate in the rhythm-based multitask training intervention

Other: Rhythm-based Multitask Training

Control group (Continuation of regular activity schedule)

NO INTERVENTION

Randomized to the control group who is encouraged to continue their regular everyday routines, which may include self-administrated training exercises.

Interventions

Rhythm-based Multitask Training OTHER

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.

Training group (Rhythm-based multitask training)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Department of Geriatric Medicine at Aalborg University

Aalborg, Northern Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jens E Nørgaard, Cand.Scient.

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, Cand.Scient.

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: February 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)