Physical Training in Sarcoidosis Patients

Physical Training in Sarcoidosis Patients With Fatigue Complaints

Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent problems in sarcoidosis. These physical impairments are disabling and affect quality of life in a negative way. The aetiology of these physical impairments is multifactorial. Physical inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness. These symptoms may be partially reversible following a structured physical training program. However, scientific studies about physical training in sarcoidosis are lacking. Therefore, the aim of the present study is to examine the changes in fatigue complaints, physical functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week physical training program.

After obtaining written informed consent, sarcoidosis patients will start a 13-week physical training program for three times a week. This training program includes peripheral muscle training for both the upper and lower extremities (starting at 40% of the multiple-repetition maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).

Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after ending the training. During these assessments, patients perform muscle strength (m. quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance cycling test). They also complete several questionnaires:

Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS)

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Behavioral: Physical training; Other: Physical training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Geleen, Limburg, Netherlands, 6161 ST
      • Fysiomedica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients are diagnosed with sarcoidosis according to the WASOG guideline.
• Fatigued patients ((FAS-score ≥ 22 points) and/or a reduced six-minute walking distance (predicted six-minute walking distance -50 m).
• Patients who signed the consent form and are able to participate in a training program.
• Minimum age 18 years and maximum age 70 years.
• Clinically stable: no exacerbation of complaints, or changes in initiated therapeutic management during the preceding 3 months.

Exclusion Criteria:

• Patients with a cognitive failure, making them unable to understand questionnaires and instructions.
• Patients with a oncological, cardiac, neurological or orthopedic history making them unable to participate in a training program.
• Patients who are unfamiliar with the Dutch language, disabling them to understand questionnaires and instructions.
• Patients who participated in a physical training program six months prior to inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical training	Behavioral: Physical training; Other: Physical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cange in Fatigue Assessment Scale (FAS)at 3 months after end of the training	The 10-item FAS is a fatigue scale. Each item has a 5-point rating scale and FAS scores range from 10-50. FAS scores <22 indicate nonfatigue persons and scores of 22-34 indicate fatigued persons.	baseline (week 0), at the end (week 13) and 3 months after ending the training

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ild care foundation
• Investigators: Principal Investigator: Antoine F. Lenssen, PhD, Maastricht University Medical Centre

Publications and helpful links

General Publications

• Marcellis RG, Lenssen AF, de Vries GJ, Baughman RP, van der Grinten CP, Verschakelen JA, De Vries J, Drent M. Is there an added value of cardiopulmonary exercise testing in sarcoidosis patients? Lung. 2013 Feb;191(1):43-52. doi: 10.1007/s00408-012-9432-6. Epub 2012 Nov 9.
• Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.
• Marcellis R, Van der Veeke M, Mesters I, Drent M, De Bie R, De Vries G, Lenssen A. Does physical training reduce fatigue in sarcoidosis? Sarcoidosis Vasc Diffuse Lung Dis. 2015 Jun 22;32(1):53-62.

Helpful Links

• ild care foundation

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Fatigue; Muscle strength; Endurance training; Resistance training; Exercise capacity; Training program
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: METC 12-3-032