Comparison of Different Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis

NCT05368883 | Completed

• 1 other identifier: Cerrahpasa University
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary rehabilitation is a key element in the management of people with chronic respiratory disease. A properly followed supervised physical training program in sarcoidosis is safe and has no absolute contraindications. Fatigue can also be associated with sarcoidosis for different reasons. Individualized rehabilitation training can improve the symptoms of patients with sarcoidosis. There is no study in the literature investigating the effectiveness of one-legged exercises that reduce peripheral muscle use, in patients with sarcoidosis. In our study, these two exercise methods will be compared by applying one-legged exercise training and two-legged exercise training. The effect of one-legged exercise training on exercise capacity and fatigue in sarcoidosis patients will be examined. The primary aim of our study is to compare the effects of one-legged exercise training, which is a current exercise approach, and two-legged exercise training on exercise capacity and fatigue in patients with sarcoidosis. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength and quality of life parameters.

Conditions

Pulmonary Sarcoidosis

Keywords

fatigue; exercise; quality of life; pulmonary sarcoidosis

Outcome Measures

Primary Outcomes (3)

• Change of Six-Minute Walking Test Distance from baseline to 8 weeks

  The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.

  8 weeks

• Change of Endurance Shuttle Walking Test Distance from baseline to 8 weeks

  Endurance Shuttle Walk test: This is a standardized field test for the assessment of endurance capacity. In the Endurance Shuttle Walk Test, the participant walks at a constant speed between cones spaced 10 m apart. The selected speed is 85% of the participant's maximum capacity measured in the shuttle walk test at increasing speed. Therefore, before this test, the patient should be given an increasing speed ıncremental shuttle walk test.

  8 weeks

• Incremental Shuttle Walk Test

  The incremental shuttle walk test (ISWT) is a field-based assessment of cardiorespiratory fitness and physical function. The ISWT is a performance-based assessment of exercise and functional capacity that measures walking distance in meters. It is a relatively brief and easy test to perform. The ISWT simulates a maximal cardiopulmonary test in a field setting and requires minimal equipment. Longer walking distances signify better performance.

  8 weeks

Secondary Outcomes (3)

• Change of Fatigue Assessment Scale results from baseline to 8 weeks

  8 weeks

• Change of Multidimensional Fatigue Inventory results from baseline to 8 weeks

  8 weeks

• Change of Blood Lactate Level from baseline to 8 weeks

  8 weeks

Other Outcomes (5)

• Dyspnoea

  8 weeks

• Muscle strength

  8 weeks

• Health Related Quality of Life

  8 weeks

Study Arms (2)

One-legged cycling ergometer training

EXPERIMENTAL

One-legged cycling ergometer training; 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks.

Other: Exercise- One-Legged

Two-legged cycling ergometer training

ACTIVE COMPARATOR

Two-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks.

Other: Exercise-Two-Legged

Interventions

Exercise- One-Legged OTHER

The exercise program consisted of a 5-minute warm-up, followed by 10 minutes of cycling for each leg during the first 2 weeks, increasing to 15 minutes for each leg in the subsequent weeks (with a 5-10 minute rest period between switching legs), and concluded with a 5-minute cool-down period. During the exercise, the inactive leg was kept stationary and in contact with the ground . In the one-legged cycling exercise training, whether patients started with the dominant or non-dominant leg was determined randomly

One-legged cycling ergometer training

Exercise-Two-Legged OTHER

The exercise program consisted of a 5-minute warm-up, followed by 20 minutes of cycling during the first 2 weeks, increasing to 30 minutes in the subsequent weeks, and concluded with a 5-minute cool-down period.

Two-legged cycling ergometer training

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease severity classified as stage 2, 3, or 4 based on chest X-ray findings FAS score ≥ 22 Patients being clinically stable No changes in their medical treatment

You may not qualify if:

• Having orthopedic, neurological, cardiac, or metabolic conditions that could hinder participation in the exercise program and adherence to it during the study period.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gökşen KURAN ASLAN

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 10, 2022
• Study Start: March 1, 2023
• Primary Completion: April 21, 2023
• Study Completion: September 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

TU (1)