Fatigue and Exercise Training in Patients With Sarcoidosis

Study Overview
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Brief Summary
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The aims of the current study is to explore if different exercise training protocols affect fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training period.

Detailed Description
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This project aims to provide data on post-exercise fatigue after single exercise sessions with endurance training and muscle strength training, each with two different intensities. For endurance training; post-exercise fatigue will be assessed after one session of high intensity interval training, and one session with longer duration of moderate intensity. For muscle strength training, fatigue will be measured after one session with high loads/few repetitions and one session with low loads/many repetitions. In addition, changes in sub-maximal and maximal metabolic and ventilatory responses to a maximal cardiopulmonary exercise test on a treadmill (CPET) and association to sarcoidosis-related fatigue before and after a 4-weeks exercise training period will be studied.

Official Title
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Fatigue and Exercise Training in Patients With Sarcoidosis

Conditions
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Sarcoidosis, Fatigue

Intervention / Treatment
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* Other: Muscle strength training
* Other: Endurance exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with sarcoidosis diagnosed according to the latest American Thoracic Society/European Respiratory Society/World Association for Sarcoidosis and Other Granulomatous Disorders (ATS/ERS/WASOG) statement on sarcoidosis who are attending a four weeks exercise based pulmonary rehabilitation program at LHL-klinikkene Glittre. Exclusion Criteria: Patients with a concurrent and predominant diagnosis of another significant respiratory disorder (for example: asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, or lung cancer). Unstable cardiovascular disease. Not able to perform the required physical tests and exercise training sessions caused by co-morbidities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Four exercise training sessions. Two endurance training sessions, one with high intensity interval training and one session of moderate intensity of longer duration. Two strength training session; one with high load and few repetitions and one with low load and many repetitions. Fatigue and lactate will be measured before, after and 24 hours post-exercise. Trainings sessions will be randomized. | Other: Muscle strength training<br>* Two different muscle strength training protocols will be compared; one exercise session with high load/low repetitions (4 sets x 5RM) versus one exercise session with low load/high repetitions (2 sets x 25RM). Both session will be conducted at four different exercises; seated leg press, chest press, cable lat pull down and seated rowing.<br>Other: Endurance exercise training<br>* Two different endurance exercise training protocols will be compared; one exercise sessions is interval training with high intensity (85-95% of HRmax) versus one of moderate intensity (70-75% of HRmax) with longer duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Changes of fatigue will be assessed assessed by Visual Analogue Scale (VAS), where the grade of fatigue is assessed between 0 (no fatigue) and 10 (maximal fatigue). | Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lactate | Blood lactate will be assessed by capillary puncture in a finger tip. | Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise. | 
| Change in sarcoidosis related fatigue | Assessed by the Fatigue Assessment Scale (FAS) | Measured first day and last day of a 4-week exercise based pulmonary rehabilitation | 
| Change in metabolic and ventilatory variables from CPET | Ratio ventilation/carbon dioxide output (VE/VCO2) | Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation | 
| Change in metabolic and ventilatory variables from CPET | Ventilatory (anaerobic) threshold (VT, %) | Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation | 
| Change in maximal oxygen uptake | Maximal oxygen uptake (VO2, mL/min) | Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoidosis, Fatigue, Exercise