Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
University of Oslo
Hasselt University
Information provided by (Responsible Party):
Anne Helene Edvardsen, 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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Fatigue Other: Muscle strength training Other: Endurance exercise training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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, %)

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Norway
LHL-klinikkene Glittre
Hakadal, Norway, 1485
Sponsors and Collaborators
LHL Helse
University of Oslo
Hasselt University
Investigators
Layout table for investigator information
Study Director: Siri Skumlien, PhD LHL Helse

Layout table for additonal information
Responsible Party: Anne Helene Edvardsen, Head of Out Patient and Laboratory Department, Researcher, LHL Helse
ClinicalTrials.gov Identifier: NCT02735161     History of Changes
Other Study ID Numbers: 2015/23131
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anne Helene Edvardsen, LHL Helse:
Sarcoidosis
Fatigue
Exercise

Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue
Sarcoidosis
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases