Primary objective: (1) To describe the relative intensity of ADL and the amount of and variability in time spent at various individually determined relative physical activity intensities (low, moderate and vigorous) during ADL in individuals with…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) The amount of time spent at low (<40%HRR), moderate (40-60%HRR), and
vigorous (>60%HRR) intensities during ADL.
ADL (active minutes) will be assessed by an ankle worn activity monitor during
7 consecutive days. During the same period, the heart rate will be assessed
with a heart rate monitor (HRADL, bpm). To determine the relative intensity of
ADL, heart rate responses will be expressed relative to the individuals* heart
rate reserve (HRR), defined as the difference between resting and peak heart
rate (HRpeak, bpm). HRpeak will be measured in a maximal exercise test.
Secondary outcome
Secondary study endpoints will include, the level of physical activity in daily
life, the relative intensity of standardized walking, muscle strength, and
self-reported ADL.
(2) Level of physical activity
ADL (active minutes) will be measured for 7 days in the individuals* own living
environment with an ankle worn activity monitor and with an activity wirstband.
(3) Relative intensity of standardized walking.
The relative intensity of standardized walking is obtained by expressing the
heart rate response (HRwalk) and oxygen uptake (VO2walk ) during a 6 minute
walk test (6MWT) at comfortable speed relative to respectively the individual
heart rate reserve (HRR) and oxygen uptake reserve (VO2R) as determined during
a maximal exercise test.
(4) Muscle strength
Muscle strength will be determined by manual muscle testing (MMT) according to
the Medical Research Council [MRC] scale. Muscle groups to be tested are hip
flexors and extensors, hip abductors and adductors, knee flexors and extensors,
and ankle dorsi- and plantarflexors.
(5) Self-reported ADL
For adequate interpretation of the data regarding ADL, subjects will be asked
to note their activity program during the day in a diary. Subjects will be
asked to note the time of getting up, type and duration of activities during
the day, and the time of going to bed. Besides, subjects are asked to indicate
for all different activities whether they were experienced as low, moderate, or
vigorous in intensity.
Background summary
Physical activity guidelines state that adults should participate in moderate
intensity physical activity for a minimum of 30 minutes, 5 days weekly; or in
vigorous intensity physical activity for a minimum of 20 minutes, 3 days weekly
in order to be beneficial for health and fitness. Individuals with
neuromuscular diseases (NMD) represent a heterogeneous group of diseases with
varying levels of muscle weakness. Consequently, the relative intensity of
physical activities of daily living (ADL) is expected to vary among individuals
and may be higher compared to healthy individuals. Insight in the amount and
relative intensity of ADL in individuals with NMD compared to healthy
individuals is needed to determine whether their daily activity levels provoke
periods of physical strain that are sufficient to maintain or enhance health
and fitness. This information is currently lacking, and is needed to develop
specific recommendations for physical activity in individuals with NMD.
Study objective
Primary objective:
(1) To describe the relative intensity of ADL and the amount of and variability
in time spent at various individually determined relative physical activity
intensities (low, moderate and vigorous) during ADL in individuals with NMD.
Secondary objectives:
(2) To compare the amount of time spent at various individually determined
relative physical activity intensities (low, moderate and vigorous) during ADL
in individuals with NMD to physical activity recommendations in healthy
individuals.
(3) To determine the relative intensity of standardized walking in individuals
with NMD in comparison with healthy individuals.
Study design
A cross-sectional study will be conducted at the outpatient clinic of the
Department of Rehabilitation at the Academic Medical Center (AMC) in Amsterdam.
Study burden and risks
Two visits to the AMC in Amsterdam will be required for all participants. The
duration of each examination will be approximately 1 hour, during which
participants perform an exercise test. In addition, participants will be asked
to wear an ankle-worn activity monitor and a heart rate monitor for 7
consecutive days between both visits. To check for contra-indications for
exercise testing, a physician will thoroughly examine the participants
according to the guidelines by the American College of Sports Medicine (ACSM).
Measurements are non-invasive. While there are no direct benefits to the
participants, the findings can be used to develop specific recommendations for
physical activity in individuals with NMD.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
(1) Diagnosed with a Neuromuscular Disease.
(2) Muscle weakness in the upper or lower extremities; e.g. a score of <5 according to the Medical Research Council [MRC] scale in one of the following muscle groups; shoulder flexors and extensors, shoulder ab- and adductors, elbow flexors and extensors, wrist flexors and extensors, hip flexors and extensors, hip abductors and adductors, knee flexors and extensors, and ankle dorsi- and plantarflexors, or signs of fat infiltration during MRI in one of the upper or lower extremity muscle groups.
(3) Minimum age of 18 years.
Exclusion criteria
(1) Insufficient mastery of the Dutch language.
(2) Cognitive impairment.
(3) Contra-indications for maximal exercise testing according to the guidelines by the American College of Sports Medicine (ACSM).
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 | NL57516.018.16 |