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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Original IPAQ followed by a revised one.
Revised IPAQ followed by an original one.
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hereditary Motor and Sensory Neuropathy focused on measuring CMT, IPAQ, NMD, Charcot-Marie-Tooth, International Physical Activity Questionnaire, neuromuscular disorders, activity diary, hereditary neuropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 3, 2020
Last Updated
February 23, 2021
Sponsor
Oslo University Hospital
Collaborators
Norwegian National Advisory Unit on Rare Disorders (NKSD), University of Oslo, Foreningen for Muskelsyke
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1. Study Identification

Unique Protocol Identification Number
NCT04461613
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian National Advisory Unit on Rare Disorders (NKSD), University of Oslo, Foreningen for Muskelsyke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Original IPAQ followed by a revised one.
Intervention Description
Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
Intervention Type
Other
Intervention Name(s)
Revised IPAQ followed by an original one.
Intervention Description
Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
Primary Outcome Measure Information:
Title
Total physical activity duration
Description
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.
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Physical activity duration for different intensities from original and revised IPAQ-sf
Description
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.
Time Frame
16 days
Title
Qualitative inputs from the pilot study participants for all of the study instruments
Description
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.
Time Frame
16 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Ørstavik, MD, Ph.D.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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