Physical Training in Sarcoidosis Patients

NCT02243995 | Completed DMC

• 1 other identifier: METC 12-3-032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Sarcoidosis

Keywords

Training program; Resistance training; Endurance training; Muscle strength; Exercise capacity; Fatigue; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Physical training

EXPERIMENTAL

Other: Physical training; Behavioral: Physical training

Interventions

Physical training OTHER

Physical training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ild care foundation: collaborator

Study Sites (1)

Fysiomedica

Geleen, Limburg, 6161 ST, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 23138855 BACKGROUND

• 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.

  PMID: 21436356 BACKGROUND

• 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.

  PMID: 26237356 DERIVED

Related Links

• ild care foundation

MeSH Terms

Conditions

Sarcoidosis; Fatigue

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antoine F. Lenssen, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: September 18, 2014
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 9, 2018

Record last verified: 2014-09

Locations

NL (1)