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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02735161
Other study ID # 2015/23131
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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