Clinical trial NCT02735161: Fatigue and Exercise Training in Patients With Sarcoidosis
Official title: Fatigue and Exercise Training in Patients With Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Fatigue
Keywords: Sarcoidosis
Fatigue
Exercise
Lead sponsor: LHL Helse
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Hasselt University
First posted: 2016-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue
timeFrame: Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.
Secondary outcomes:
measure: Change in blood lactate
timeFrame: Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise.
measure: Change in sarcoidosis related fatigue
timeFrame: Measured first day and last day of a 4-week exercise based pulmonary rehabilitation
measure: Change in metabolic and ventilatory variables from CPET
timeFrame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
measure: Change in metabolic and ventilatory variables from CPET
timeFrame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
measure: Change in maximal oxygen uptake
timeFrame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: LHL-klinikkene Glittre
Study officials:
affiliation: LHL Helse
name: Siri Skumlien, PhD
role: STUDY_DIRECTOR
References: