Effect of Thoracic Mobilization in People With Central Obesity

Official title

Effect of Mulligan Thoracic Mobilization on Ventilatory Functions and Chest Wall Expansion in Central Obesity

Overview

The goal of this clinical trial is to learn whether Mulligan thoracic mobilization in extension improves ventilatory functions and chest wall expansion in adults with central obesity. It will also evaluate whether adding Mulligan thoracic mobilization to a low-carbohydrate diet and aerobic exercise provides greater benefits than diet and exercise alone. The main questions it aims to answer are: Does Mulligan thoracic mobilization improve ventilatory functions (FVC, FEV₁, FEV₁/FVC ratio, and MVV) in adults with central obesity? Does Mulligan thoracic mobilization improve chest wall expansion, functional capacity, and health-related quality of life? Researchers will compare Mulligan thoracic mobilization combined with a low-carbohydrate diet and aerobic exercise to a low-carbohydrate diet and aerobic exercise alone to determine whether the addition of thoracic mobilization improves respiratory outcomes. Participants will: Be randomly assigned to either the intervention group or the control group. Receive an individualized low-carbohydrate diet and supervised aerobic exercise for 8 weeks. Receive Mulligan thoracic mobilization in extension five times per week for 8 weeks if assigned to the intervention group. Undergo assessments of ventilatory functions, chest wall expansion, functional capacity, and quality of life before and after the intervention.

Detailed description

The Challenge: Central Obesity and Respiratory Dysfunction

Central obesity is a growing global health concern that affects not only metabolic and cardiovascular health but also respiratory function. Excess accumulation of abdominal and visceral fat mechanically restricts chest wall movement, limits diaphragmatic excursion, and reduces lung volumes, leading to impaired ventilatory function and decreased chest wall expansion. These respiratory limitations can contribute to dyspnea, reduced exercise tolerance, and poorer quality of life. Although weight loss through dietary modification and aerobic exercise remains the cornerstone of obesity management, these approaches do not directly address the mechanical restrictions imposed on the thoracic cage. Therefore, additional physiotherapy interventions targeting thoracic mobility may provide further improvements in respiratory function.

The Goal of the Study

This study aims to determine whether adding Mulligan thoracic mobilization in extension to a standardized low-carbohydrate diet and aerobic exercise program provides greater improvements in ventilatory functions and chest wall expansion than diet and exercise alone in adults with central obesity. The study will also investigate whether this intervention improves functional exercise capacity and health-related quality of life.

How the Study Works

The study will involve 60 adult males with central obesity who meet the study eligibility criteria. Participants will be randomly assigned into two equal groups:

The Mulligan Thoracic Mobilization Group: Participants will receive Mulligan thoracic mobilization in extension performed by a trained physiotherapist five times per week for eight weeks. The mobilization will be applied to the mid-thoracic spine (T6-T8) using the Mobilization with Movement (MWM) concept while participants perform thoracic extension combined with deep inspiration. In addition, participants will follow an individualized low-carbohydrate diet and participate in a supervised aerobic exercise program.

The Control Group: Participants will receive the same individualized low-carbohydrate diet and supervised aerobic exercise program without Mulligan thoracic mobilization.

Both groups will participate in the intervention program for 8 weeks, with regular monitoring to ensure adherence and participant safety.

What Is Being Measured?

To determine the effectiveness of the intervention, the study will evaluate several important clinical outcomes:

Ventilatory Functions: Pulmonary function will be assessed using spirometry by measuring Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV₁), the FEV₁/FVC ratio, and Maximum Voluntary Ventilation (MVV).

Chest Wall Expansion: Chest wall mobility will be measured using a non-elastic tape measure at the fourth intercostal space and at the xiphoid process during maximal inspiration and expiration.

Functional Capacity: The Six-Minute Walk Test (6MWT) will be used to assess participants' functional exercise capacity.

Health-Related Quality of Life: Participants will complete the 36-Item Short Form Health Survey (SF-36) to evaluate physical and mental aspects of quality of life.

Why This Matters

Respiratory impairment associated with central obesity is largely driven by mechanical restriction of the thorax, yet current obesity management strategies rarely address this component directly. By investigating the effects of Mulligan thoracic mobilization in extension, this study aims to identify a safe, non-invasive, and clinically practical physiotherapy intervention that can complement conventional weight management. If effective, this approach may improve respiratory mechanics, enhance chest wall mobility, increase functional capacity, and improve quality of life for adults with central obesity while expanding the evidence base for manual therapy in cardiopulmonary rehabilitation.

Interventions

• Procedure Mulligan Thoracic Mobilization
  * Technique: Thoracic mobilization with movement (MWM) in extension performed by a trained physiotherapist. * Performed 5×/week. * Total program duration: 8 weeks. * 3 sets × 10 repetitions per spinal level per session. * Hold time: thoracic extension maintained for approximately 6 seconds at the end of the movement. * Participant position: sitting at the edge of the treatment table with hands behind the neck. * Therapist technique: mobilizing force applied using the ulnar border of the hand ove
• Behavioral low carbohydrate
  Standardized low-carbohydrate dietary program administered for 8 weeks.
• Behavioral Aerobic Exercise
  Moderate-intensity aerobic exercise program for 8 weeks, 5 sessions per week, at 55-69% HRmax or Borg RPE 12-14, progressing from 30 to 45 minutes per session.

Primary outcome measures

• Forced Vital Capacity [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Forced Expiratory Volume in One Second [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Ratio of Forced Expiratory Volume in One Second to Forced Vital Capacity [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Maximum Voluntary Ventilation [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Chest Wall Expansion at the Fourth Intercostal Space [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Chest Wall Expansion at the Xiphoid Process Level [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]

Secondary outcome measures (2)

• Functional capacity [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]
• Change in Health-Related Quality of Life [Time frame: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).]

Eligibility criteria

Inclusion criteria

• Males aged 25-35 years.
• Presence of central obesity, defined as:

• Waist circumference ≥102 cm in males.
• Waist-hip ratio (WHR) ≥0.90 in males.
• BMI from 30-39.9 kg/m².
• Willing to comply with conventional physiotherapy (diet and exercise) and mobilization programs.
• Medically stable individuals with a restrictive lung pattern (Normal FEV₁/FVC ratio and FVC < 80% of predicted).
• Low level physical activity (using the International Physical Activity Questionnaire-Short Version).
• Non-smokers.

Exclusion criteria

• Diagnosed COPD, asthma, or other chronic respiratory diseases.
• Recent thoracic spine or rib injury/surgery.
• Cardiovascular instability or uncontrolled hypertension.
• Contraindications to manual therapy (e.g., osteoporosis, rib fractures, or spinal tumors).
• Participation in any structured weight loss program or exercise regimen in the past 6 months.
• History of bariatric surgery (e.g., gastric sleeve, gastric bypass).
• Use of medications that affect body weight or metabolism (e.g., corticosteroids, antipsychotics, weight loss drugs).
• Neurological or musculoskeletal conditions that limit mobility or exercise participation and interfere with gait.
• Any acute respiratory infections in the past 6 weeks.

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

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07718178 · CU-AA-19052026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗