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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
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Jens Eg Nørgaard, Aalborg University Hospital

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.


Condition or disease Intervention/treatment Phase
Accidental Fall Fall Injury Other: Rhythm-based Multitask Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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.



Primary Outcome Measures :
  1. Fall rate (falls per person-years) [ Time Frame: 12 months following the randomization ]
    Fall calendar


Secondary Outcome Measures :
  1. Number of falls, number of fallers/non-/multiple-fallers, and time to first fall [ Time Frame: 12 months following the randomization ]
    Fall calendar

  2. Number of fall-related injuries [ Time Frame: 12 months following the randomization ]
    Fall-calendar, verified by radiologically evidence

  3. Number of fall-related hospital admissions [ Time Frame: 12 months following the randomization ]
    Fall-calendar, verified by medical journals

  4. 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

  5. Single- and dual-task balance [ Time Frame: Baseline, six months, and 12 months ]
    30-second static balance; dual-task: Grocery verbal fluency

  6. Choice stepping reaction time [ Time Frame: Baseline, six months, and 12 months ]
    Choice stepping reactions test on a Wii balance board

  7. Lower extremity physical performance [ Time Frame: Baseline, six months, and 12 months ]
    The Short Physical Performance Battery

  8. 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

  9. Fear of Falling [ Time Frame: Baseline, six months, and 12 months ]
    The Short Falls Efficacy Scale international, Danish version

  10. Loneliness [ Time Frame: Baseline, six months, and 12 months ]
    The UCLA Loneliness Scale, Danish version

  11. Executive function [ Time Frame: Baseline, six months, and 12 months ]
    The Trail Making task Part A and B

  12. Frailty [ Time Frame: Baseline and 12 months ]
    The Tilburg Frailty Indicator



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Geriatric Medicine at Aalborg University
Aalborg, Northern Jutland, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Aalborg University
Investigators
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Principal Investigator: Jens E Nørgaard, Cand.Scient. Aalborg University Hospital
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Responsible Party: Jens Eg Nørgaard, PhD-student, Cand.Scient., Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04620421    
Other Study ID Numbers: N-20200019
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jens Eg Nørgaard, Aalborg University Hospital:
Older adults
Dual-task
Gait adaptability
Multitask
Music-based exercise
Fall prevention
Exercise
Quality of Life
Dalcroze Eurhythmics