SarcoidosisNCT00099424
Exercise Training in Sarcoidosis (EXTRAS Study)
A study testing High-intensity exercise training in people with Sarcoidosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- High-intensity exercise training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2004to Aug 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)
Who cannot join
- A history of neurosarcoidosis
- Undergoing structured exercise training at the time of enrollment or in the preceding 6 months
- Current participation in a pharmacological study
- Cardiovascular abnormalities on the ECG during baseline peak exercise test
- A 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial
Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:
- A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
- A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
- A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
Read the detailed description
The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.
- Conditions
- Sarcoidosis
- Being tested
- High-intensity exercise training
- Keywords
- exercise training, resistance training, endurance training, Boeck's Sarcoid, Besnier-Boeck Disease
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity exercise trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status: Medical Outcomes Study 36-Item Short-Form Health Survey
Disease-specific quality of life: Sarcoidosis Health Questionnaire
Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer
Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load
Functional exercise capacity (II): the distance walked in 6 minutes
Secondary outcomes (6)
Pulmonary function: forced vital capacity and transfer factor for carbon monoxide
Muscle function: isometric quadriceps femoris muscle peak torque
Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75
Anxiety and depression: Hospital Anxiety and Depression Scale
Health-related quality of life (I): Chronic Respiratory Disease Questionnaire
Health-related quality of life (II): St. George's Respiratory Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2004 (estimated)
- Study startFeb 2004
- Study completionAug 2005
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Martijn A. Spruit, PhD, Principal investigator, KU LeuvenMarc Decramer, PhD MD, Study director, University Hospital, GasthuisbergMichiel J. Thomeer, MD, Study chair, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099424
- Sponsor's protocol ID
- ML2563
- Status last verified
- Jun 2008
- First submitted
- 13 Dec 2004
- Last updated
- 5 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT00099424
- Acronym / sponsor ID
- ML2563
- Conditions
- Sarcoidosis
- Keywords
- exercise training, resistance training, endurance training, Boeck's Sarcoid, Besnier-Boeck Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Aug 2005
- First posted
- 14 Dec 2004 (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.
Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:
- A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
- A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
- A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
Detailed description
The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)
Key exclusion criteria (5 listed)
- A history of neurosarcoidosis
- Undergoing structured exercise training at the time of enrollment or in the preceding 6 months
- Current participation in a pharmacological study
- Cardiovascular abnormalities on the ECG during baseline peak exercise test
- A 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes
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 |
|---|---|---|
| High-intensity exercise training | Behavioural | – |
Primary outcome
Health status: Medical Outcomes Study 36-Item Short-Form Health Survey
Disease-specific quality of life: Sarcoidosis Health Questionnaire
Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer
Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load
Functional exercise capacity (II): the distance walked in 6 minutes
6 secondary outcomes
Pulmonary function: forced vital capacity and transfer factor for carbon monoxide
Muscle function: isometric quadriceps femoris muscle peak torque
Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75
Anxiety and depression: Hospital Anxiety and Depression Scale
Health-related quality of life (I): Chronic Respiratory Disease Questionnaire
Health-related quality of life (II): St. George's Respiratory Questionnaire
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 5 Jun 2008.
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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.
Martijn A. Spruit, PhD principal investigator
KU Leuven
Marc Decramer, PhD MD study director
University Hospital, Gasthuisberg
Michiel J. Thomeer, MD study chair
University Hospital, Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity exercise training in people with Sarcoidosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 5 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 5 Jun 2008. 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 Belgium. 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?
Health status: Medical Outcomes Study 36-Item Short-Form Health Survey. The study lists 5 primary outcomes in all. 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 5 Jun 2008.