Accidental FallRYMANCT04620421
Effect of Rhythm-based Multitask Training on Falls Among Older Adults
A study testing Rhythm-based Multitask Training in people with Accidental Fall and Fall Injury, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Fall Injury
- What is being tested?
- Rhythm-based Multitask Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Geriatric Medicine at Aalborg University
Aalborg, Northern Jutland, 9000
About this study
Official title: 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.
Read the 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.
- Conditions
- Accidental Fall, Fall Injury
- Being tested
- Rhythm-based Multitask Training
- Keywords
- Older adults, Dual-task, Gait adaptability, Multitask, Music-based exercise, Fall prevention, Exercise, Quality of Life, Dalcroze Eurhythmics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm-based Multitask TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training group (Rhythm-based multitask training) | Experimental | Randomized to participate in the rhythm-based multitask training intervention Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate (falls per person-years)
Fall calendar
Measured: 12 months following the randomization
Secondary outcomes (12)
Number of falls, number of fallers/non-/multiple-fallers, and time to first fall
Fall calendar
Measured: 12 months following the randomization
Number of fall-related injuries
Fall-calendar, verified by radiologically evidence
Measured: 12 months following the randomization
Number of fall-related hospital admissions
Fall-calendar, verified by medical journals
Measured: 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
Measured: Baseline, six months, and 12 months
Single- and dual-task balance
30-second static balance; dual-task: Grocery verbal fluency
Measured: Baseline, six months, and 12 months
Choice stepping reaction time
Choice stepping reactions test on a Wii balance board
Measured: Baseline, six months, and 12 months
Lower extremity physical performance
The Short Physical Performance Battery
Measured: Baseline, six months, and 12 months
Health-related quality of life
The EuroQoL EQ-5D-5L, Danish version
Measured: Baseline, six months, 12 months, and during phone-interview following a registered fall
Fear of Falling
The Short Falls Efficacy Scale international, Danish version
Measured: Baseline, six months, and 12 months
Loneliness
The UCLA Loneliness Scale, Danish version
Measured: Baseline, six months, and 12 months
Executive function
The Trail Making task Part A and B
Measured: Baseline, six months, and 12 months
Frailty
The Tilburg Frailty Indicator
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Jens Eg Nørgaard, Aalborg University Hospital
- Investigators
- Jens E Nørgaard, Cand.Scient., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620421
- Sponsor's protocol ID
- N-20200019
- Acronym
- RYMA
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rhythm-based Multitask Training on Fall Rate in Community-dwelling Older Adults: An Assessor-blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04620421
- Acronym / sponsor ID
- RYMA / N-20200019
- Conditions
- Accidental Fall, Fall Injury
- Keywords
- Older adults, Dual-task, Gait adaptability, Multitask, Music-based exercise, Fall prevention, Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Training group (Rhythm-based multitask training) | Experimental | Other: Rhythm-based Multitask TrainingRandomized to participate in the rhythm-based multitask training intervention |
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythm-based Multitask TrainingParticipants 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. | Other | Training group (Rhythm-based multitask training) |
Primary outcome
Fall rate (falls per person-years)
Time frame: 12 months following the randomization
Fall calendar
12 secondary outcomes
Number of falls, number of fallers/non-/multiple-fallers, and time to first fall
Time frame: 12 months following the randomization
Number of fall-related injuries
Time frame: 12 months following the randomization
Number of fall-related hospital admissions
Time frame: 12 months following the randomization
Single- and dual-task gait
Time frame: Baseline, six months, and 12 months
Single- and dual-task balance
Time frame: Baseline, six months, and 12 months
Choice stepping reaction time
Time frame: Baseline, six months, and 12 months
Lower extremity physical performance
Time frame: Baseline, six months, and 12 months
Health-related quality of life
Time frame: Baseline, six months, 12 months, and during phone-interview following a registered fall
Fear of Falling
Time frame: Baseline, six months, and 12 months
Loneliness
Time frame: Baseline, six months, and 12 months
Executive function
Time frame: Baseline, six months, and 12 months
Frailty
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens E Nørgaard, Cand.Scient. principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythm-based Multitask Training in people with Accidental Fall and Fall Injury, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall rate (falls per person-years) (time frame: 12 months following the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.