Physical Activity in Persons With Charcot-Marie-Tooth: Developing a Measurement Instrument

NCT ID: NCT04461613

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-04-30

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.

Conditions

Hereditary Motor and Sensory Neuropathy; Charcot-Marie-Tooth; Polyneuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Group 1

In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 1 will receive an original International Physical Activity Questionnaire short form (IPAQ-sf). Group 1 will be asked to fill it out with information about physical activities in the last 7 days.

In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 1 will be asked to fill a revised version of IPAQ-sf to describe physical activities in the last 7 days.

Group Type: EXPERIMENTAL

Original IPAQ followed by a revised one.

Intervention Type: OTHER

Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.

Group 2

In the first week, this group will receive a physical activity diary and be required to fill it out for 7 days. After completion of the activity diary, group 2 will receive a revised version of International Physical Activity Questionnaire short form (IPAQ-sf). Group 2 will be asked to fill it out with information about physical activities in the last 7 days.

In the second week, the group will need to fill another physical activity diary for 7 days. After the completion of this, group 2 will be asked to fill an original IPAQ-sf to describe physical activities in the last 7 days.

Group Type: EXPERIMENTAL

Revised IPAQ followed by an original one.

Intervention Type: OTHER

Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.

Interventions

Original IPAQ followed by a revised one.

Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.

Intervention Type: OTHER

Revised IPAQ followed by an original one.

Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian National Advisory Unit on Rare Disorders (NKSD)

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Foreningen for Muskelsyke

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristin Ørstavik

Consultant in Neurology and Head of Section for Rare Neuromuscular disorders including EMAN, Department of Neurology, Oslo University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Ørstavik, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2020/94587

Identifier Type: -

Identifier Source: org_study_id