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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02735161 |
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Date of registration:
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28/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fatigue and Exercise Training in Patients With Sarcoidosis
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Scientific title:
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Fatigue and Exercise Training in Patients With Sarcoidosis |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02735161 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Siri Skumlien, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LHL Helse |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fatigue
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Sarcoidosis
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Intervention(s)
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Other: Endurance exercise training
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Other: Muscle strength training
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Primary Outcome(s)
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Change in fatigue
[Time Frame: Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.]
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Secondary Outcome(s)
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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]
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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.]
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Change in sarcoidosis related fatigue
[Time Frame: Measured first day and last day of a 4-week exercise based pulmonary rehabilitation]
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Change in maximal oxygen uptake
[Time Frame: Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation]
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Secondary ID(s)
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2015/23131
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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