Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04620421 |
| Other study ID # |
N-20200019 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Aalborg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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.
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.
