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Physical Training in Sarcoidosis Patients

Physical Training in Sarcoidosis Patients With Fatigue Complaints

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02243995
Enrollment
40
Registered
2014-09-18
Start date
2013-01-31
Completion date
2014-05-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Keywords

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

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)

Interventions

OTHERPhysical training

Sponsors

ild care foundation
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cange in Fatigue Assessment Scale (FAS)at 3 months after end of the trainingbaseline (week 0), at the end (week 13) and 3 months after ending the trainingThe 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026