Fatigue and Exercise Training in Patients With Sarcoidosis

Fatigue Clinical Trial

Official title:

Fatigue and Exercise Training in Patients With Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735161
• Other study ID #: 2015/23131
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: August 22, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Sarcoidosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	LHL-klinikkene Glittre	Hakadal

Sponsors (3)

Lead Sponsor	Collaborator
LHL Helse	Hasselt University, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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