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NCT Number: NCT06680960

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

About this study

The investigators aimed to determine the effects of an aerobic exercise training program, resistance exercise training, and an additional trunk stabilization training program in individuals with COPD.

Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Data collection tools and exercise training programs will be made by the same researchers. A total of 44 COPD patients, 22 in each group, will be included in the study.

COPD individuals who agree to participate in the study will be randomised electronically using a randomisation program and participants will be divided into two groups.

Group 1: Aerobic exercise training and resistance exercise training and trunk stabilisation strength training Group 2: Aerobic exercise training, resistance exercise training and respiratory exercise training

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Trunk stabilisation exercises

Other

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

Respiratory exercises

Other

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

Primary outcomes

  1. Maximal exercise capacity

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Forced expiratory volume (FEV1)

    Time frame: 8 weeks

    It is the volume of air exhaled in the first second from the beginning of the forced vital capacity maneuver. This parameter will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS). If this value is below eighty percent, it indicates the presence of airway obstruction.

  2. Forced Vital Capacity (FVC)

    Time frame: 8 weeks

    It is the volume of air exhaled rapidly and forcefully following deep inspiration. Healthy people can normally exhale 80% of their lung volume in 6 seconds or less. In people with severe obstruction, this period may take up to 20 seconds. This parameter will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS).

  3. Respiratory muscle strength

    Time frame: 8 weeks

    Respiratory muscle strength will be assessed with a portable, electronic oral pressure measuring device (Cosmed Pony Fx, Milan, Italy). Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Percentage of expected reference values according to gender and age will be used for the MIP value. The clinical significance for this patient group is 17.2 cmH2O for the measured MIP value.

  4. COPD Assessment Questionnaire

    Time frame: 8 weeks

    The COPD Assessment Test (CAT) will be used to assess health status impairment in individuals with COPD. The CAT is an eight-item test consisting of questions that evaluate the severity of symptoms such as dyspnea, cough, and sputum production and the impact of the disease on daily life. It is recommended that the minimal clinical significance is a change of 2 points.

  5. Muscle activity

    Time frame: 8 weeks

    Muscle activity of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated. Muscle activity will be evaluated using surface electromyography (EMG) (Neuro-MEP, Ivanovo, Russia). There is no cut-off value for these parameters in this patient group. The changes will be stated numerically and as a percentage as a result of the evaluations of the patients before and after the exercise training.

  6. Muscle Thickness

    Time frame: 8 weeks

    Muscle thickness of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated. Muscle thickness will be evaluated using ultrasound (LOGIQ P9, GE Healthcare, USA). There is no cut-off value for these parameters in this patient group. The changes will be stated numerically and as a percentage as a result of the evaluations of the patients before and after the exercise training.

  7. Timed up and go test

    Time frame: 8 weeks

    The Timed Up and Go Test (TUG) will be used for the balance assessment of individuals participating in the study. TUG is a frequently used, easily applicable, valid and reliable, performance-based functional mobility and balance test that evaluates dynamic balance in the clinic. It has been shown that dynamic balance impairment in COPD is associated with inadequate oxygenation and peripheral muscle weakness. Individuals who complete the test in 12 seconds or more have a risk of falling. This test, which has different cut-off values according to some disease groups, has a value of 13.5 seconds for general adults.

  8. Functional reach test

    Time frame: 8 weeks

    Functional reach test will be used for the balance assessment of individuals participating in the study. Individuals who can reach 25 cm and more have a low risk of falling. Individuals who can reach between 15-25 cm have a 2 times higher risk of falling than normal. Individuals who can reach 15 cm and below have a 4 times higher risk of falling than normal. Individuals who cannot reach at all have an 8 times higher risk of falling than normal.

  9. St George Health Questionnaire

    Time frame: 8 weeks

    St. George's Respiratory Questionnaire (SGRQ), a seventy-six-item health-related quality of life assessment questionnaire, will be used to assess the quality of life of the subjects.The result values are between 0 and 100 and the higher the value, the greater the degree to which the patient's quality of life is affected by the disease. Minimal significant variability in the treatment response follow-up was stated as a 4 point change.

  10. Hospital Anxiety and Depression Scale

    Time frame: 8 weeks

    The Hospital Anxiety and Depression (HAD) scale will be used to determine the anxiety and depression levels of individuals participating in the study. This scale is a self-report scale that includes anxiety and depression subscales and consists of 14 items, seven of which investigate depression and seven of which investigate anxiety levels.The cut-off point for the anxiety subscale of the HAD Turkish form was found to be 10 and the cut-off point for the depression subscale was found to be 7. Patients who score above these points can be considered as a risk group. Anxiety and depression score 07: normal, 8-11: borderline, >11: anxiety and depression

  11. Six Minute Walk Test (6MWT)

    Time frame: 8 weeks

    6MWT will be used to evaluate the exercise capacities of individuals who will participate in the study. The individuals' walking distance and cardiac parameters during the test will be recorded.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Effects of Different Exercise Approaches on Exercise Capacity, Muscle Parameters and Quality of Life in Chronic Obstructive Pulmonary Disease Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

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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