About this trial
The primary aim of this study is to investigate the effects of manual therapy on spatiotemporal characteristics of gait and gait variability, functional exercise capacity, and pulmonary function in patients with chronic obstructive pulmonary disease (COPD).
The secondary aims of the study are to determine the effects of manual therapy on balance, respiratory muscle strength, quality of life, physical activity, symptom severity, accessory respiratory muscle activation, peripheral muscle strength, chest wall mobility, dysfunctional breathing, pain, and posture.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 years or older
Clinically stable for at least the past 4 weeks
Classified as GOLD stage 1, 2, or 3 according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) airflow limitation classification
Classified as group A, B, or E according to the GOLD ABE assessment tool
Disqualifiers
Use of walking assistive devices
Receiving long-term oxygen therapy
Presence of additional orthopedic, neuromuscular, neurological, or cardiac conditions that may affect gait and balance
History of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery
Trial design
Parallel
Treatments tested in this trial
Manual therapy Group
Other interventionFor muscle energy techniques, the post-isometric relaxation (PIR) technique will be applied. Participants will be instructed to perform an isometric contraction against mild resistance (20-30% of maximal effort), which will be maintained for 7-10 seconds, followed by a 3-second relaxation period. PIR applications will be performed bilaterally for each muscle group, in 2 sets with a total of 10 repetitions. The muscle groups to which MET will be applied include the pectoralis major and minor, upper trapezius, scalene muscles, sternocleidomastoid, and latissimus dorsi. For the diaphragmatic relaxation technique, the therapist will follow the elevation of the ribs and gently draw the contact points cranially and slightly laterally. During expiration, the therapist will maintain resistance by deepening the contact toward the internal costal margin. The maneuver will be applied in two sets of 10 deep breaths, with a 1-minute rest interval between sets.
Control group
Other interventionSelf-stretching and breathing exercise
Treatment groups
Trial outcomes
Primary outcomes
Spatiotemporal Gait Characteristics (Gait Analysis)
The spatiotemporal characteristics of gait and gait variability will be assessed using an electronic walkway system (GAITRite, CIR Systems Inc., Franklin, New Jersey, USA). GAITRite is a system with established reliability and validity for gait assessment in individuals with COPD. Data will be collected at the beginning and at the end of a six-minute walking period. Participants will walk at their self-selected pace. Gait data obtained at the beginning and at the end of the six-minute walk will be averaged for data analysis. Data normalization will be performed using participants' leg length (cm), height (cm), or body weight (kg) values.
Spatial Gait Distance Parameters
Mean step length, stride length, and step width measured using the GAITRite electronic walkway system. Unit of Measure: meters (m)
Temporal Gait Parameters
Mean stance phase duration, swing phase duration, stride time, and step time assessed using GAITRite. Unit of Measure: seconds (s)
Gait Speed
Mean walking speed measured using the GAITRite system during self-selected pace walking. Unit of Measure: meters per second (m/s)
Secondary outcomes
Respiratory muscle strength
Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) generated at the mouth using a mouth pressure device (Micro MPM; Micro Medical Ltd., Rochester, UK) with individual antibacterial and antiviral disposable filters. For MIP measurement, participants will be instructed to perform a maximal expiration; after the application of a nose clip, they will then perform a maximal inspiration for 1-3 seconds. For MEP measurement, participants will be instructed to perform a maximal inspiration; after the application of a nose clip, they will then perform a maximal expiration for 1-3 seconds. The tests will be repeated until no further improvement is observed and the difference between the two best values is less than 5%. The highest value will be recorded. Predicted normal values for respiratory muscle strength will be calculated using age- and sex-specific regression equations.
Peripheral muscle strength
Peripheral muscle strength will be assessed using handgrip strength and the one-minute sit-to-stand test. Handgrip strength will be measured using a digital hand dynamometer (Baseline BIMS, Fabrication Enterprises Inc., USA).Participants will be instructed to grip the stabilized dynamometer with maximal force. Measurements will be repeated three times, and the highest value will be recorded. Participants will be seated freely on a chair with a height of 46 cm, with the hips and knees flexed at 90°, arms crossed over the chest, and feet positioned at hip width. They will then be instructed to stand up and sit down as many times as possible within one minute at their self-selected pace, without altering body posture. The total number of repetitions will be recorded. This repetition count will be expressed as a percentage of predicted reference values adjusted for sex, height, body weight, and age.
Balance assessment
Balance and postural sway will be assessed using a three-component force platform (Bertec Model BP 5050; Bertec Corporation, Columbus, Ohio, USA). Participants will be asked to stand barefoot on the force platform for 10 seconds while maintaining a quiet standing position with a stance width equal to their support base. Postural sway will be evaluated under four different conditions: eyes open and eyes closed on both firm and compliant surfaces. Based on the data, a stability score calculated by the device software will also be expressed as a percentage. Stability limits in the anterior, posterior, right, and left directions will be recorded in centimeters and expressed as percentages.
Accessory Muscle activation
Surface electromyography will be used to assess accessory respiratory muscle activation using the Trigno™ system (Delsys Inc., Natick, MA, USA). Four channels will be utilized for data acquisition. To minimize signal crosstalk, electrode placement will be determined in accordance with the recommendations of the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) guidelines. Activation of the most commonly investigated accessory respiratory muscles will be assessed bilaterally at rest. The muscles evaluated will include the sternocleidomastoid, pectoralis major, upper trapezius, and latissimus dorsi. A standardized maximal voluntary contraction (MVC) protocol will be applied for each muscle. EMG values will be normalized to the MVC obtained for the corresponding muscle and expressed as a percentage of MVC (%MVC).
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