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

Official title

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

Overview

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.

Detailed description

Musculoskeletal changes secondary to systemic inflammation in chronic obstructive pulmonary disease (COPD) negatively affect both ventilatory efficiency and ventilation-perfusion matching during walking, leading to a reduction in functional capacity. Current and conventional pulmonary rehabilitation approaches generally aim to improve aerobic capacity, muscle strength, and respiratory muscle endurance. However, aspects such as thoracic spine mobility, costotransverse and costovertebral joint biomechanics, the craniocaudal positioning of the diaphragm, and accessory respiratory muscle activation are still not adequately addressed in existing rehabilitation programs. The effects of manual therapy applied to the thoracic region, trunk, and accessory respiratory muscles on both exercise capacity and the spatiotemporal characteristics of gait have not yet been clearly established. Given the multisystem involvement in COPD, the application of manual therapy-an intervention with a high level of evidence in the management of other musculoskeletal conditions-offers an innovative approach to treatment. It is plausible that muscle energy techniques, one of the manual therapy methods, may reduce hypertonicity in excessively activated accessory respiratory muscles during breathing and thereby enhance chest wall expansion. In the existing literature, the limited number of studies investigating manual therapy interventions in COPD have primarily focused on pulmonary function and exercise capacity; however, there is still no consensus regarding the outcomes. Considering the biomechanical connection between the thoracic cage and the trunk and extremities, it can be hypothesized that manual therapies in COPD may influence gait by affecting lower extremity movements. In this context, manual therapy may impact not only respiratory parameters but also gait performance through the interaction between biomechanics, respiration, and posture in patients with COPD.

Interventions

• Other Manual therapy Group
  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, upp
• Other Control group
  Self-stretching and breathing exercise

Primary outcome measures

• Spatiotemporal Gait Characteristics (Gait Analysis) [Time frame: At the baseline and after the eight-week intervention]
• Spatial Gait Distance Parameters [Time frame: At the baseline and after the eight-week intervention]
• Temporal Gait Parameters [Time frame: At the baseline and after the eight-week intervention]
• Gait Speed [Time frame: At the baseline and after the eight-week intervention]
• Cadence [Time frame: At the baseline and after the eight-week intervention]
• Gait Symmetry and Asymmetry Indices [Time frame: At the baseline and after the eight-week intervention]
• Gait Variability Parameters [Time frame: At the baseline and after the eight-week intervention]
• Functional exercise capacity [Time frame: At the baseline and after the eight-week intervention]
• Pulmonary Functions [Time frame: At baseline and after the eight-week intervention]
• Forced Vital Capacity (FVC) [Time frame: At the baseline and after the eight-week intervention]

Secondary outcome measures (12)

• Respiratory muscle strength [Time frame: At the baseline and after the eight-week intervention]
• Peripheral muscle strength [Time frame: At the baseline and after the eight-week intervention]
• Balance assessment [Time frame: At the baseline and after the eight-week intervention]
• Accessory Muscle activation [Time frame: At the baseline and after the eight-week intervention]
• Posture [Time frame: At the baseline and after the eight-week intervention]
• Chest wall assessment [Time frame: At the baseline and after the eight-week intervention]
• Dyspnea Level [Time frame: At the baseline and after the eight-week intervention]
• Severity of symptoms [Time frame: At the baseline and after the eight-week intervention]
• Severity of disease [Time frame: At the baseline and after the eight-week intervention]
• Severity of disease and mortality [Time frame: At the baseline and after the eight-week intervention]
• Quality of life (St. George's Respiratory Questionnaire ) [Time frame: At the baseline and after the eight-week intervention]
• Physical Activity (International Physical Activity Questionnaire) [Time frame: At the baseline and after the eight-week intervention]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Hacettepe University — Ankara

Identifiers

NCT: NCT07381842 · FTREK25/173

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗