Investigation of the Effects of Different Exercise Approaches on Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients

NCT06680960 | Active Not Recruiting DMC

• 1 other identifier: AEŞH-BADEK-2024-553-
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (COPD) are well known. Standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. No study has been found in the literature that includes a trunk stabilization training program that includes muscles that provide whole body stabilization in COPD patients.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

copd; exercise training; trunk stabilisation; muscle parameters

Outcome Measures

Primary Outcomes (1)

• Maximal exercise capacity

  Maximal exercise capacity will be assessed by cardiopulmonary exercise testing (CPET) using a workload protocol of increasing intensity. Monitoring will be provided with 12-lead electrocardiography at rest, during testing and recovery. During CPET, data will be recorded with the "breathe-by-breathe" method through a face mask and a gas analyzer.

  8 weeks

Secondary Outcomes (11)

• Forced expiratory volume (FEV1)

  8 weeks

• Forced Vital Capacity (FVC)

  8 weeks

• Respiratory muscle strength

  8 weeks

• COPD Assessment Questionnaire

  8 weeks

• Muscle activity

  8 weeks

Study Arms (2)

Trunk Stabilisation Exercise Group

ACTIVE COMPARATOR

Other: Trunk stabilisation exercises

Respiratory Exercise Group

ACTIVE COMPARATOR

Other: Respiratory exercises

Interventions

Trunk stabilisation exercises OTHER

This exercise program includes aerobic exercise, resistance exercise and trunk stabilisation training for eight weeks.

Trunk Stabilisation Exercise Group

Respiratory exercises OTHER

This exercise program includes aerobic exercise, resistance exercise and respiratory exercise training for eight weeks.

Respiratory Exercise Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of COPD
• Being between the ages of 40-80
• Being clinically stable (not having had an exacerbation in the last month)
• Being able to cooperate with the tests
• Not participating in any exercise training studies
• Being willing to participate in the study

You may not qualify if:

• Having other lung or lung involvement diseases other than COPD
• Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
• Being hemodynamically unstable
• Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
• Having a history of neuromuscular disease, scoliosis, chest wall surgery
• Being pregnant and having a malignancy
• Having an orthopedic or surgical problem that would prevent participation in tests and exercise training
• Not being willing to participate in the study

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, M.Sc

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 8, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

TU (1)