Back to resultsFatigue and Exercise Training in Patients With Sarcoidosis
Primary Purpose
Sarcoidosis, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Muscle strength training
Endurance exercise training
Sponsored by
About this trial
This is an interventional other trial for Sarcoidosis focused on measuring Sarcoidosis, Fatigue, Exercise
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.
Sites / Locations
- LHL-klinikkene Glittre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise training
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in blood lactate
Blood lactate will be assessed by capillary puncture in a finger tip.
Change in sarcoidosis related fatigue
Assessed by the Fatigue Assessment Scale (FAS)
Change in metabolic and ventilatory variables from CPET
Ratio ventilation/carbon dioxide output (VE/VCO2)
Change in metabolic and ventilatory variables from CPET
Ventilatory (anaerobic) threshold (VT, %)
Change in maximal oxygen uptake
Maximal oxygen uptake (VO2, mL/min)
Full Information
NCT ID
NCT02735161
First Posted
March 28, 2016
Last Updated
August 22, 2017
Sponsor
LHL Helse
Collaborators
University of Oslo, Hasselt University
1. Study Identification
Unique Protocol Identification Number
NCT02735161
Brief Title
Fatigue and Exercise Training in Patients With Sarcoidosis
Official Title
Fatigue and Exercise Training in Patients With Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LHL Helse
Collaborators
University of Oslo, Hasselt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Fatigue
Keywords
Sarcoidosis, Fatigue, Exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Muscle strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Endurance exercise training
Intervention Description
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 Measure Information:
Title
Change in fatigue
Description
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).
Time Frame
Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.
Secondary Outcome Measure Information:
Title
Change in blood lactate
Description
Blood lactate will be assessed by capillary puncture in a finger tip.
Time Frame
Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise.
Title
Change in sarcoidosis related fatigue
Description
Assessed by the Fatigue Assessment Scale (FAS)
Time Frame
Measured first day and last day of a 4-week exercise based pulmonary rehabilitation
Title
Change in metabolic and ventilatory variables from CPET
Description
Ratio ventilation/carbon dioxide output (VE/VCO2)
Time Frame
Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Title
Change in metabolic and ventilatory variables from CPET
Description
Ventilatory (anaerobic) threshold (VT, %)
Time Frame
Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Title
Change in maximal oxygen uptake
Description
Maximal oxygen uptake (VO2, mL/min)
Time Frame
Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Skumlien, PhD
Organizational Affiliation
LHL Helse
Official's Role
Study Director
Facility Information:
Facility Name
LHL-klinikkene Glittre
City
Hakadal
ZIP/Postal Code
1485
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Fatigue and Exercise Training in Patients With Sarcoidosis
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