Fatigue and Exercise Training in Patients With Sarcoidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02735161|
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis Fatigue||Other: Muscle strength training Other: Endurance exercise training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fatigue and Exercise Training in Patients With Sarcoidosis|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Exercise training
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
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.
Other: Endurance exercise training
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.
- Change in fatigue [ Time Frame: Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise. ]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).
- Change in blood lactate [ Time Frame: Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise. ]Blood lactate will be assessed by capillary puncture in a finger tip.
- Change in sarcoidosis related fatigue [ Time Frame: Measured first day and last day of a 4-week exercise based pulmonary rehabilitation ]Assessed by the Fatigue Assessment Scale (FAS)
- Change in metabolic and ventilatory variables from CPET [ Time Frame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation ]Ratio ventilation/carbon dioxide output (VE/VCO2)
- Change in metabolic and ventilatory variables from CPET [ Time Frame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation ]Ventilatory (anaerobic) threshold (VT, %)
- Change in maximal oxygen uptake [ Time Frame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation ]Maximal oxygen uptake (VO2, mL/min)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735161
|Hakadal, Norway, 1485|
|Study Director:||Siri Skumlien, PhD||LHL Helse|