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

NCT04461613 | Unknown

• 1 other identifier: 2020/94587
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physical activity duration for different intensities from original and revised IPAQ-sf

  16 days

• Qualitative inputs from the pilot study participants for all of the study instruments

  16 days

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Group 2

EXPERIMENTAL

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.

Interventions

Original IPAQ followed by a revised one. OTHER

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

Group 1

Revised IPAQ followed by an original one. OTHER

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

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian National Advisory Unit on Rare Disorders (NKSD): collaborator
• University of Oslo: collaborator
• Foreningen for Muskelsyke: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Hereditary Sensory and Motor Neuropathy; Charcot-Marie-Tooth Disease; Polyneuropathies; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Kristin Ørstavik, MD, Ph.D.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Study participants will receive an unmarked envelope consisting of all study material. The order of the study questionnaires inside the unmarked envelope will be randomized and sealed by the first researcher. The first researcher will give them to the second researcher who will again shuffle the envelopes order (without the first researcher present) before giving them to the care provider. The care provider will give the study envelope to the study participants. Therefore, investigators and care provider will be masked to the contents of the unmarked study envelope and cannot selectively assign the participants to a certain group. However, the study participants might recognize the original IPAQ if she/he received this questionnaire in the past.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Neurology and Head of Section for Rare Neuromuscular disorders including EMAN, Department of Neurology, Oslo University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: September 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)