SarcoidosisNCT02735161
Fatigue and Exercise Training in Patients With Sarcoidosis
A study testing Muscle strength training and Endurance exercise training in people with Sarcoidosis and Fatigue, run by LHL Helse at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sarcoidosis, Fatigue
- What is being tested?
- Muscle strength training and Endurance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis, Fatigue
- Being tested
- Muscle strength training, Endurance exercise training
- Keywords
- Sarcoidosis, Fatigue, Exercise
- Medical subject headings
- Sarcoidosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 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. Receives: Other: Muscle strength training; Other: Endurance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.
Secondary outcomes (5)
Change in blood lactate
Blood lactate will be assessed by capillary puncture in a finger tip.
Measured: Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise.
Change in sarcoidosis related fatigue
Assessed by the Fatigue Assessment Scale (FAS)
Measured: Measured first day and last day of a 4-week exercise based pulmonary rehabilitation
Change in metabolic and ventilatory variables from CPET
Ratio ventilation/carbon dioxide output (VE/VCO2)
Measured: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Change in metabolic and ventilatory variables from CPET
Ventilatory (anaerobic) threshold (VT, %)
Measured: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Change in maximal oxygen uptake
Maximal oxygen uptake (VO2, mL/min)
Measured: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Hasselt University
- Responsible party
- Principal investigator, Anne Helene Edvardsen, LHL Helse
- Investigators
- Siri Skumlien, PhD, Study director, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735161
- Sponsor's protocol ID
- 2015/23131
- Other IDs
- 2015
- Status last verified
- Aug 2017
- First submitted
- 28 Mar 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Exercise Training in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT02735161
- Acronym / sponsor ID
- 2015/23131
- Conditions
- Sarcoidosis, Fatigue
- Keywords
- Sarcoidosis, Fatigue, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Collaborators
- University of Oslo, Hasselt University
- Study start
- Apr 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Muscle strength training, Other: Endurance exercise trainingFour 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strength trainingTwo 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 | Exercise training |
| Endurance exercise trainingTwo 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. | Other | Exercise training |
Primary outcome
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).
5 secondary outcomes
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.
Change in sarcoidosis related fatigue
Time frame: Measured first day and last day of a 4-week exercise based pulmonary rehabilitation
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
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
Change in maximal oxygen uptake
Time frame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Skumlien, PhD study director
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strength training and Endurance exercise training in people with Sarcoidosis and Fatigue, run by LHL Helse at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.