Clinical trial NCT04461613: Physical Activity in Persons With Charcot-Marie-Tooth: Developing a Measurement Instrument
Official title: Developing and Testing Instrument to Measure Physical Activity in Charcot-Marie-Tooth: a Pilot Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary Motor and Sensory Neuropathy
Charcot-Marie-Tooth
Polyneuropathies
Keywords: CMT
IPAQ
NMD
Charcot-Marie-Tooth
International Physical Activity Questionnaire
neuromuscular disorders
activity diary
hereditary neuropathy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian National Advisory Unit on Rare Disorders (NKSD)
name: University of Oslo
name: Foreningen for Muskelsyke
First posted: 2020-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two groups of people with CMT will compare an original International Physical Activity Questionnaire short form (IPAQ-sf) and a revised one with a 7-days physical activity diary. The first group will begin with the original version and end with a revised one. The second group will begin with a revised IPAQ-sf and end with the original one. Both groups will also need to complete a 7-days activity diary two times.
Primary purpose: SCREENING

Brief summary: The project will develop knowledge about physical activity in persons with Charcot-Marie-Tooth (CMT) in Norway. We plan to explore instruments to measure physical activity level for the target-group at the community level. We want to understand which type of activities, activity intensities and how persons with CMT perform habitual physical activity. Subsequently, a physical activity measurement instrument adapted to persons with CMT will be developed. This instrument can be used in a future intervention project to promote physical activity in this group.

Detailed description: Charcot-Marie-Tooth (CMT) is a condition that potentially affects daily life function including physical activity. Currently, there is no specific treatment. To prevent physical deconditioning, physical activity recommended. Furthermore, other studies have found the benefit of being physically active, including people with neuromuscular disorders (NMD). .

Apart from the physical activity in a rehabilitation center, physical activity also needs to be maintained at the community level in people's everyday life. To measure physical activity level in the community, we need an instrument that is designed for doing so. A questionnaire can be used to collect information about type of activity, activity duration and intensity. The instruments available so far to measure physical activity at the community level are not specifically adapted to persons with CMT. Therefore, this study will focus on revising the questionnaire based on the inputs from persons with CMT themselves. Furthermore, the revised questionnaire will be compared with the original one in addition to yet another instrument.

Eligibility criteria: Inclusion Criteria:

* Adults with a genetically confirmed CMT diagnosis.
* Residing in Norway
* Age between 18 to 65 years old.

Exclusion Criteria:

* Had major surgery within three months prior to the study period.
* Experiencing serious illness (e.g. bedridden, hospitalized).

Primary outcomes:
measure: Total physical activity duration
timeFrame: 16 days
Secondary outcomes:
measure: Physical activity duration for different intensities from original and revised IPAQ-sf
timeFrame: 16 days
measure: Qualitative inputs from the pilot study participants for all of the study instruments
timeFrame: 16 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristin Ørstavik, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: