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Trial record 45 of 229 for:    strength | Norway

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

Tracking Information
First Submitted Date  ICMJE March 28, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date August 23, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • 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.
  • 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)
  • 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)
  • 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, %)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatigue and Exercise Training in Patients With Sarcoidosis
Official Title  ICMJE Fatigue and Exercise Training in Patients With Sarcoidosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Sarcoidosis
  • Fatigue
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.

Interventions:
  • Other: Muscle strength training
  • Other: Endurance exercise training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735161
Other Study ID Numbers  ICMJE 2015/23131
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anne Helene Edvardsen, LHL Helse
Study Sponsor  ICMJE LHL Helse
Collaborators  ICMJE
  • University of Oslo
  • Hasselt University
Investigators  ICMJE
Study Director: Siri Skumlien, PhD LHL Helse
PRS Account LHL Helse
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP