Fatigue and Exercise Training in Patients With Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis; Fatigue
• Interventions: Other: Muscle strength training; Other: Endurance exercise training

• Registration Number: NCT02735161
• Lead Sponsor: LHL Helse

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-03-28
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise training	Muscle strength 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.
Exercise training	Endurance 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.

Primary Outcome Measures

Name	Time	Method
Change in fatigue	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).

Secondary Outcome Measures

Name	Time	Method
Change in blood lactate	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 metabolic and ventilatory variables from CPET	Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation	Ventilatory (anaerobic) threshold (VT, %)
Change in sarcoidosis related fatigue	Measured first day and last day of a 4-week exercise based pulmonary rehabilitation	Assessed by the Fatigue Assessment Scale (FAS)
Change in maximal oxygen uptake	Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation	Maximal oxygen uptake (VO2, mL/min)

Trial Locations

Locations (1)

LHL-klinikkene Glittre; 🇳🇴 Hakadal, Norway