Testing a Tailored Home Exercise Program to Reduce Pain and Fatigue in Patients with FSHD. (GRIPonFSHD)

November 26, 2024 updated by: Radboud University Medical Center

Testing a Tailored Home Exercise Program to Gain Insight Into Performance Fatigability and Reduce Pain and Fatigue in Patients with FSHD: the GRIP on FSHD Study

The goal of this intervention study is to determine the effect of a tailored exercise program (with aerobic, strength and balance training) in patients with FSHD.

The main aim is to determine the effect of the exercise program on pain and fatigue.

Participants will follow a 16 week training program with tailored exercises. The exercises will be prescribed via the app 'Physitrack'. After 16 weeks, the effect on pain, fatigue, fatigability, aerobic capacity, balance, physical function, sleep and the ability to participate in social activities will be determined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: Pain and fatigue are two common and disabling symptoms in FSHD. No studies in FSHD have proven to reduce pain yet. (Aerobic) exercise has proven to reduce fatigue, however, current training guidelines are generic which can lead to overuse of injuries. The investigators expect that a personalized training program with aerobic exercise but also strength and balance training, that is adapted to a participants symptoms and wishes will provide a positive effect on pain and fatigue.

Objectives:

Primary objectives

  1. To determine the effect of a tailored exercise program by using the widely implemented exercise app "Physitrack" on experienced pain and fatigue in patients with FSHD.
  2. To investigate the relationship between perceived pain and fatigue and performance fatigability, disease severity, clinical phenotype, and level of activity in patients with FSHD Secondary objectives

1. To determine the responsiveness of the performance fatigability test. 2. To investigate the influence of a decreasing performance fatigability on experienced fatigue 3. To provide input for new training guidelines for people with FSHD. Study design: Single group intervention study with historical control group. Study population: 50 individuals with FSHD >18 years Intervention: An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.

Main study parameters/endpoints:

The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale and the average daily pain score during 2 weeks are the primary endpoints.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study includes: (1) two visits to the Radboudumc (approximately 3-4 hours, including a break) with physical test and questionnaires, (2) following a 16 week personalized exercise program, including filling in questionnaires about pain and fatigue and (3) wearing an activity tracker for 1 week before and after the study. Participants will have a weekly phone call with the researcher, and when participants will have complaints such as pain and/or fatigue, the training will be adapted. Therefore, the investigators expect that the risk will be minimal, and patient might experience the benefits of personalized training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years
  • Verified diagnosis of FSHD type 1, based on the clinical criteria established by Padberg et al. (1991) (22).
  • Category A or B of the four clinical categories according to the Comprehensive Clinical Evaluation Form (23), these patients have the most peculiar signs of the disease
  • A CIS-fatigue score of ≥ 35
  • Owning of and being able to use a smartphone
  • Preserved ability to ambulate at the time of the selection
  • No pulmonary or cardiological involvement, that could interfere with physical training.
  • Absence of central or peripheral nervous system involvement as from neurological history and physical assessment
  • Absence of limb contractures and tendon retractions

Exclusion Criteria:

  • Use of beta-blocker medication
  • Presence of additional diseases likely to interfere with the measurements
  • Psychological-psychiatric disorders
  • A musculoskeletal injury that impairs exercising
  • Scoliosis that impairs training
  • Recent adjustment of any medications or medications that may impact fatigue or taking stimulants for fatigue (e.g., Modafinil, amantadine)
  • Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study
  • Pregnant women
  • Patient incapable of understanding the purpose and conditions of the study, incapable of giving consent or using the app
  • Patient deprived of liberty or patient under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Behavioral: Personalised Exercise
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Active Comparator: Historical control group
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)
Behavioral: Historical control group
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily observed pain
Time Frame: 16 weeks
Daily observed pain during a period of 2 weeks, measured with the Visual Analog Scale (VAS)
16 weeks
Fatigue
Time Frame: 16 weeks
The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance fatigability
Time Frame: 16 weeks
The quadriceps isometric intermittent fatigue test (QIF test)
16 weeks
Fatigue (VAS)
Time Frame: 16 weeks
VAS fatigue
16 weeks
Aerobic capacity
Time Frame: 16 weeks
B-FIT Exercise test
16 weeks
Long function
Time Frame: 16 weeks
Maximal expiratory pressure (MEP)
16 weeks
Long function
Time Frame: 16 weeks
Forced vital capacity (FVC)
16 weeks
Long function
Time Frame: 16 weeks
Maximal inspiratory pressure (MIP)
16 weeks
Balance
Time Frame: 16 weeks
Mini Balance Evaluation Systems Test (Mini-BESTest)
16 weeks
Pain Questionnaire
Time Frame: 16 weeks
Brief pain inventory questionnaire
16 weeks
Sleep
Time Frame: 16 weeks
PROMIS Short Form v1.0 - Sleep Disturbance 8a
16 weeks
Social roles an participation
Time Frame: 16 weeks
PROMIS Short Form v2.0 - Ability to Participate in Social Roles and Activities 8a
16 weeks
Physical Function
Time Frame: 16 weeks
PROMIS Short Form v2.0 - Physical Function 20a.
16 weeks
Physical activity
Time Frame: 16 weeks
Activity tracker
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Università di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL86789.091.24

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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