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

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: Not yet recruiting
• Conditions: FSHD
• Intervention / Treatment: Behavioral: Personalised Exercise; Behavioral: Historical control group

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronne van Haaren - Pater; Phone Number: +31 24 36 68 195; Email: Ronne.vanHaaren@radboudumc.nl

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Daily observed pain	Daily observed pain during a period of 2 weeks, measured with the Visual Analog Scale (VAS)	16 weeks
Fatigue	The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance fatigability	The quadriceps isometric intermittent fatigue test (QIF test)	16 weeks
Fatigue (VAS)	VAS fatigue	16 weeks
Aerobic capacity	B-FIT Exercise test	16 weeks
Long function	Maximal expiratory pressure (MEP)	16 weeks
Long function	Forced vital capacity (FVC)	16 weeks
Long function	Maximal inspiratory pressure (MIP)	16 weeks
Balance	Mini Balance Evaluation Systems Test (Mini-BESTest)	16 weeks
Pain Questionnaire	Brief pain inventory questionnaire	16 weeks
Sleep	PROMIS Short Form v1.0 - Sleep Disturbance 8a	16 weeks
Social roles an participation	PROMIS Short Form v2.0 - Ability to Participate in Social Roles and Activities 8a	16 weeks
Physical Function	PROMIS Short Form v2.0 - Physical Function 20a.	16 weeks
Physical activity	Activity tracker	16 weeks

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Università di Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Aerobic exercise; Pain; Fatigue; Balance training; Strength training; Smartphone application; Fatigability; Personalized exercise
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID 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