Fatigue and Exercise Training in Patients With Sarcoidosis

August 22, 2017 updated by: Anne Helene Edvardsen, LHL Helse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Hakadal, Norway, 1485
        • LHL-klinikkene Glittre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Assessed by the Fatigue Assessment Scale (FAS)
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
Ratio ventilation/carbon dioxide output (VE/VCO2)
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
Ventilatory (anaerobic) threshold (VT, %)
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
Maximal oxygen uptake (VO2, mL/min)
Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LHL Helse

Collaborators

University of Oslo
Hasselt University

Investigators

  • Study Director: Siri Skumlien, PhD, LHL Helse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/23131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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