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

NCT ID: NCT05368883

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-09-01

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.

Detailed Description

Pulmonary rehabilitation is a key element in the management of individuals with chronic respiratory disease. A properly followed supervised physical training program in sarcoidosis is safe and has no absolute contraindications. Fatigue may be associated with different causes in sarcoidosis. Individualized rehabilitation practices 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. 26 patients will be randomly divided into 2 groups (n1=n2=13). While one group will receive one-legged cycling ergometer training, the other group will receive two-legged cycling ergometer training. After 8 weeks of exercise training, patients will be evaluated with, Pulmonary Function Test, Six-Minute Walk Test, Endurance Shuttle Walk test, Fatigue Assessment Scale, Multidimensional Fatigue Inventory, Blood Lactate Level (with lactate device), Medical Research Council Dyspnea Scale, Handheld dynamometer, St. George's Respiratory Questionnaire. 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. The completion of the study will contribute to the determination of the content of the exercise programs to be applied in sarcoidosis patients and will reveal the effectiveness of one-legged exercise training, which is a current exercise method, in sarcoidosis patients.

Conditions

Pulmonary Sarcoidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

One-legged cycling ergometer training

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

Group Type: EXPERIMENTAL

Exercise- One-Legged

Intervention Type: 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

Two-legged cycling ergometer training

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

Group Type: ACTIVE_COMPARATOR

Exercise-Two-Legged

Intervention Type: 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.

Interventions

Exercise- One-Legged

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

Intervention Type: OTHER

Exercise-Two-Legged

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Tuğçe Tahmaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökşen KURAN ASLAN

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Cerrahpasa University

Identifier Type: -

Identifier Source: org_study_id