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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hereditary Motor and Sensory Neuropathy; Polyneuropathies; Charcot-Marie-Tooth
• Intervention / Treatment: Other: Original IPAQ followed by a revised one.; Other: Revised IPAQ followed by an original one.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Norwegian National Advisory Unit on Rare Disorders (NKSD); Foreningen for Muskelsyke
• Investigators: Principal Investigator: Kristin Ørstavik, MD, Ph.D., Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: International Physical Activity Questionnaire; neuromuscular disorders; CMT; Charcot-Marie-Tooth; IPAQ; NMD; activity diary; hereditary neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy
• Other Study ID Numbers: 2020/94587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No