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Physical Training in Sarcoidosis Patients

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Physical training
Physical training
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Training program, Resistance training, Endurance training, Muscle strength, Exercise capacity, Fatigue, Quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fysiomedica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2013
Last Updated
January 5, 2018
Sponsor
Maastricht University Medical Center
Collaborators
ild care foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02243995
Brief Title
Physical Training in Sarcoidosis Patients
Official Title
Physical Training in Sarcoidosis Patients With Fatigue Complaints
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ild care foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
Training program, Resistance training, Endurance training, Muscle strength, Exercise capacity, Fatigue, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Type
Behavioral
Intervention Name(s)
Physical training
Primary Outcome Measure Information:
Title
Cange in Fatigue Assessment Scale (FAS)at 3 months after end of the training
Description
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.
Time Frame
baseline (week 0), at the end (week 13) and 3 months after ending the training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine F. Lenssen, PhD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fysiomedica
City
Geleen
State/Province
Limburg
ZIP/Postal Code
6161 ST
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23138855
Citation
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.
Results Reference
background
PubMed Identifier
21436356
Citation
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.
Results Reference
background
PubMed Identifier
26237356
Citation
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.
Results Reference
derived
Links:
URL
http://ildcare.eu
Description
ild care foundation

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Physical Training in Sarcoidosis Patients

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