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

Polyneuropathies Clinical Trial

Official title:

Developing and Testing Instrument to Measure Physical Activity in Charcot-Marie-Tooth: a Pilot Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04461613
• Other study ID #: 2020/94587
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Charcot-Marie-Tooth
• Charcot-Marie-Tooth Disease
• Hereditary Motor and Sensory Neuropathy
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Polyneuropathies

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Foreningen for Muskelsyke, Norwegian National Advisory Unit on Rare Disorders (NKSD), University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total physical activity duration	Correlations of the total physical activity duration measured using original and revised International Physical Activity Questionnaire short form (IPAQ-sf) with an activity diary (in minutes/week).; The original IPAQ-sf has been used in Norwegian context and available in Norwegian language. It has a criterion validity of 0.30 (95% CI 0.23-0.36) against accelerometer count and 0.30-0.46 for correlation with a physical activity diary physical activity level (in MET minutes/week). The content of the revised IPAQ-sf was formulated based on the inputs from experts, including the persons with CMT themselves in our reference group. The revised IPAQ-sf will be compared with the original IPAQ-sf in this pilot project.	16 days
Secondary	Physical activity duration for different intensities from original and revised IPAQ-sf	Correlations of the physical activity duration at three different intensities: high/vigorous, moderate, and light/walking, measured using original and revised IPAQ-sf with an activity diary (in minutes/week).; Both original and revised IPAQ-sf can provide description of physical activity level in three different intensities: high/vigorous, moderate, and light/walking. In the activity diary, the Borg's scale will be used to describe intensity in categories: high, moderate, and light. The Borg's scale has weighted mean validity coefficients 0.57-0.72 for various physiological measurements, including: heart rate, blood lactate, %VO2max, VO2, ventilation, and respiration rate.	16 days
Secondary	Qualitative inputs from the pilot study participants for all of the study instruments	Inputs and comments from pilot study participants for the original IPAQ-sf, revised IPAQ-sf, and activity diary.; In this pilot project, we provided field for comments for each point of question in all three questionnaires: original IPAQ-sf, revised IPAQ-sf, and physical activity diary. These qualitative inputs will be analysed for further development and improvement of the study instruments.	16 days