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Completed

NCT Number: NCT02735161

Fatigue and Exercise Training in Patients With Sarcoidosis

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.

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Key information

Conditions

Sarcoidosis Behavior Fatigue Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHL-klinikkene Glittre

Hakadal, 1485, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Muscle strength training

Other

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 training

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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, %)

  5. 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)

Sponsors and collaborators

Lead sponsor

LHL Helse

Other

Collaborators

  • Hasselt University
  • University of Oslo

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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