Primary objective:(1) To evaluate the efficacy of a personally tailored physical activity program on the physical fitness of individuals with slowly progressive NMD, compared to usual care. Secondary objectives:(2) To evaluate the efficacy of a…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Physical fitness
The primary endpoint will be the change in peak oxygen uptake directly after
intervention.
Secondary outcome
(2) Daily activity
Measured through heart rate monitoring during 7 consecutive days, to establish
the total time spent in low, moderate and vigorous intensity activities.
Activity monitors will be used to determine the total step count during the 7
day period and subjects will also be asked to keep an activity diary.
(3) Health-related quality of life
Assessed using the Dutch version of the Short Form 36-item Health Survey
(SF36). The physical health component scores and mental health component scores
will be calculated, using age-correlated means and standard deviations of a
healthy Dutch population.
(4) Perceived physical functioning
Administered with the ACTIVLIM questionnaire. ACTIVLIM is a questionnaire on
self-reported activity limitations that was validated using the Rasch model.
The questionnaire consists of 22 daily activities of which the perceived
difficulty in performing the activity is scored.
(5) Muscle strength
The maximal voluntary torque (MVT) of the upper extremities elbow flexors and
shoulder abductors), or lower extremities (hip flexors, knee extensors and
plantar flexors) will be determined, depending on the selected exercise mode
for training. Subjects will perform three maximal-effort contractions at an
angular velocity of 60°/sec on a fixed dynamometer (Biodex System 4, New York,
USA. The highest value of peak torque (Nm) will be used for the analyses.
Creatine kinase will be determined from the blood sample.
(6) Markers of metabolic syndrome
Blood lipids and fasting glucose, assessed from blood samples and blood
pressure.
(7) Self-efficacy
Self-efficacy will be assessed with the following question *How confident are
you that you will be physically active in the following situations*, including
feeling tired, bad mood, do not have the time, on vacation, and, want to be
active outside, but bad weather, rated on a 5-point Likert scale (1=absolutely
no confidence, 5=completely confident).
(8) Physical capacity
Assessed with the 6-min walk test (6MWT), or 6-min push test (6MPT) in case of
wheelchair-bound participants.
Background summary
There is strong evidence that physical activity has positive effects on
physical and mental health, quality of life, and prevention of health problems
in the general non-disabled population, and that physical inactivity is
associated with a range of chronic diseases and early deaths. People with
neuromuscular diseases (NMD) engage less in physical activity than non-disabled
people, and generally represent a sedentary and deconditioned segment of the
population. Although an increasing number of studies in slowly progressive NMD
has demonstrated positive (short-term) effects of aerobic exercise on physical
fitness, overall evidence is inconclusive due to several negative studies. It
remains unclear what the optimal training approach is, and how to support
successful transition from supervised exercise to home or community exercise to
preserve an active lifestyle in the long term. Therefore, we developed the
theory-based, personally tailored physical activity program I*M FINE (IMproving
FItness in NEuromuscular diseases), combining aerobic training and a coaching
program, for slowly progressive NMD, specifically focusing on post-polio and
post-polio syndrome (PPS) and Charcot-Marie-Tooth disease (CMT).
Study objective
Primary objective:
(1) To evaluate the efficacy of a personally tailored physical activity program
on the physical fitness of individuals with slowly progressive NMD, compared to
usual care.
Secondary objectives:
(2) To evaluate the efficacy of a personally tailored physical activity program
on daily activity, quality of life, physical functioning, muscle strength,
markers of metabolic syndrome and self-efficacy in individuals with slowly
progressive NMD, compared to usual care.
(3) To study underlying mechanisms of improving physical fitness and daily
activity in individuals with slowly progressive NMD.
Study design
A multicenter, assessor-blinded, randomized controlled trial.
Intervention
Participants will be randomized (ratio 1:1) to the intervention group,
receiving a 6-month personalized physical activity program according to the I*M
FINE strategy, or a control group, receiving usual care.
Study burden and risks
All patients will be asked to visit the Academic Medical Center at 4 times over
the study period of 18 months to collect a blood sample, participate in a
physical examination and to fill out questionnaires. The duration of these
examinations will be approximately 2 hours . Additionally, patients will be
asked to wear a heart rate monitor for 7 consecutive days at the 4 different
time measurements. There are no costs related to the interventions for the
patients. To check for contra-indications for physical activity, a physician
will thoroughly examine the participants according to the guidelines by the
American College of Sports Medicine (ACSM) and a rest ECG will be reviewed by a
cardiologist. All participating centers are well experienced in providing
exercise therapy in patients with different neuromuscular diseases. Therefore,
the occurrence of medical events is considered minimal. Considering the
positive effects of exercise therapy known from preliminary research it can be
concluded that the benefits outweigh the burden and minimal risk associated
with this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
(1) Prior paralytic poliomyelitis (confirmed by signs of residual weakness and
atrophy of muscles on neuromuscular examination, and with EMG) or diagnosis of
PPS (according to the March of Dimes criteria), CMT (confirmed by DNA testing
or polyneuropathy compatible with CMT and positive family history), or other
slowly progressive NMD (with no effective drug therapy).
(2) Presence of a question for help indicative of impaired physical fitness or
physical inactivity.
(3) Minimum age of 18 years.
Exclusion criteria
(1) Contraindication for being physically active (according to the guidelines
by the American College of Sports Medicine).
(2) Unable to follow verbal or written instructions.
(3) Insufficient mastery of the Dutch language.
(4) Engaged in an exercise program for a period longer than 4 weeks during the
last 6 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62104.018.17 |