The Effects of Manual Therapy on the Spatiotemporal Gait Characteristics in Patients With Chronic Obstructive Pulmonary Disease

NCT07381842 | Not Yet Recruiting

• 1 other identifier: FTREK25/173
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Manuel Therapy; Gait Biomechanics; Muscle Energy Technique; Functional Capacity

Keywords

COPD; Gait; Manuel therapy

Outcome Measures

Primary Outcomes (13)

• 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.

  At the baseline and after the eight-week intervention

• Spatial Gait Distance Parameters

  Mean step length, stride length, and step width measured using the GAITRite electronic walkway system. Unit of Measure: meters (m)

  At the baseline and after the eight-week intervention

• Temporal Gait Parameters

  Mean stance phase duration, swing phase duration, stride time, and step time assessed using GAITRite. Unit of Measure: seconds (s)

  At the baseline and after the eight-week intervention

• Gait Speed

  Mean walking speed measured using the GAITRite system during self-selected pace walking. Unit of Measure: meters per second (m/s)

  At the baseline and after the eight-week intervention

• Cadence

  Mean cadence assessed using GAITRite during the six-minute walk test. Unit of Measure: steps per minute (steps/min)

  At the baseline and after the eight-week intervention

• Gait Symmetry and Asymmetry Indices

  Right-left gait symmetry and asymmetry indices derived from spatiotemporal gait parameters. Unit of Measure: ratio or percentage (%)

  At the baseline and after the eight-week intervention

• Gait Variability Parameters

  Stride time variability, step time variability, and step width variability calculated from GAITRite data. Unit of Measure: coefficient of variation (%)

  At the baseline and after the eight-week intervention

• Functional exercise capacity

  Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The test will be conducted in accordance with the criteria of the American Thoracic Society (ATS). Heart rate and peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter (Nonin Model 2500C, Nonin Medical, Inc., Plymouth, Minnesota, USA), and blood pressure will be measured using a sphygmomanometer (Erka Perfect Aneroid, Berlin, Germany) before the test, at the first minute, and immediately after the test. Leg fatigue, general fatigue, and dyspnea will be assessed using the Modified Borg Scale. At the end of the test, the total distance walked will be recorded in meters. Predicted values based on age, sex, height, and body weight will be used to calculate the percentage of the predicted walking distance achieved by each participant. To evaluate mechanical workload, the 6MWT workload will be calculated by multiplying the six-minute walking distance by the participant's body weight.

  At the baseline and after the eight-week intervention

• Pulmonary Functions

  Pulmonary functions will be assessed using spirometry in accordance with the guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Forced expiratory volume in one second (FEV₁) will be recorded. FEV₁ expressed as a percentage of predicted values based on reference equations. Unit of Measure: Percentage (%) Based on spirometry results, airflow limitation in COPD will be classified according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) criteria, with FEV₁/FVC \< 0.70 defined for all groups. Classification will be as follows: * GOLD 1 (Mild): FEV₁ ≥ 80% of predicted * GOLD 2 (Moderate): 50% ≤ FEV₁ \< 80% of predicted * GOLD 3 (Severe): 30% ≤ FEV₁ \< 50% of predicted * GOLD 4 (Very severe): FEV₁ \< 30% of predicted

  At baseline and after the eight-week intervention

• Forced Vital Capacity (FVC)

  Forced vital capacity (FVC) measured by spirometry following ATS/ERS standards. Unit of Measure: Liters (L) an persantage (%)

  At the baseline and after the eight-week intervention

• FEV₁/FVC Ratio

  The ratio of forced expiratory volume in one second to forced vital capacity (FEV₁/FVC) obtained from spirometry. Unit of Measure: Ratio

  At the baseline and after the eight-week intervention

• Peak Expiratory Flow (PEF)

  Peak expiratory flow assessed by spirometry according to ATS/ERS guidelines. Unit of Measure: Liters per second (L/s) and persentage (%)

  At the baseline and after the eight-week intervention

• Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)

  Forced expiratory flow between 25% and 75% of forced vital capacity measured using spirometry. Unit of Measure: Liters per second (L/s) and persentage

  At the baseline and after the eight-week intervention

Secondary Outcomes (14)

• Respiratory muscle strength

  At the baseline and after the eight-week intervention

• Peripheral muscle strength

  At the baseline and after the eight-week intervention

• Balance assessment

  At the baseline and after the eight-week intervention

• Accessory Muscle activation

  At the baseline and after the eight-week intervention

• Posture

  At the baseline and after the eight-week intervention

Study Arms (2)

Manual therapy Group

EXPERIMENTAL

Muscle energy techniques and diaphragmatic relaxation techniques

Other: Manual therapy Group

Control Group

OTHER

Respiratory exercises and stretching exercises Stretching will be applied to the following muscle groups: pectoralis major and minor, upper trapezius, scalene muscles, sternocleidomastoid, and latissimus dorsi.

Other: Control group

Interventions

Manual therapy Group OTHER

For 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.

Manual therapy Group

Control group OTHER

Self-stretching and breathing exercise

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Presence of musculoskeletal conditions such as fibromyalgia, rheumatoid arthritis, or osteoarthritis
• Presence of a known mental or cognitive impairment

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

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)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aynur Demirel

  Hacettepe University

  STUDY CHAIR

Central Study Contacts

Aynur Demirel, PT, PhD, Assoc. Prof.

CONTACT

+903051576168; aynur.demirel@hacettepe.edu.tr

Hidaye Yamikan, PT, MSc.

CONTACT

+905349898724; hidaye.yamikan@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The all participants will be blinded. The outcome assessor who will participate in the gait analysis, balance assessment, and EMG analysis will blind to participant allocation. Participants will be randomized into the intervention and control groups using a computer-based randomization sequence with a 1:1 allocation ratio. Allocation concealment will be ensured using sequentially numbered, sealed, and opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Assoc. Prof.

Model Details: Participants will be randomized into two group using a computer-based method, taking potential stratification criteria (such as sex, age, and disease severity) into account. The Manual Therapy Group and Control Group. After randomization, manual techniques will be applied in patients with COPD in intervention group. Study design: Double-blind randomized controlled trial

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 2, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): January 8, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)