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Effect of Thoracic Mobilization in People With Central Obesity

2026. július 28. frissítette: Abd El-Rahman Ayman Mohamed Abd El-Monem, Cairo University

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

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

60

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

  • Név: Alaa N Abdelhameed
  • Telefonszám: 00201061382864

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Mulligan Thoracic Mobilization
will receive Mulligan thoracic mobilization in extension five times per week for 8 weeks in addition to a standardized diet and aerobic exercise.
Eljárás: 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 over the spinous process in a cephalic-anterior direction.
  • Movement performed: deep inspiration combined with thoracic extension during the mobilization.
  • Target levels: Mid-thoracic region (T6-T8).
  • Session duration: The session duration was based on three sets of ten repetitions per spinal level, with each repetition held for approximately 6 seconds. A 30-second rest interval was provided between sets, resulting in an effective application time of about 4-5 minutes per level.
Viselkedési: low carbohydrate
Standardized low-carbohydrate dietary program administered for 8 weeks.
Viselkedési: 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.
Aktív összehasonlító: low carbohydrate and Aerobic Exercises
will receive standardized diet and aerobic exercise.
Viselkedési: low carbohydrate
Standardized low-carbohydrate dietary program administered for 8 weeks.
Viselkedési: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Forced Vital Capacity
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Measured in liters using spirometry.
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Forced Expiratory Volume in One Second
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Measured in liters using spirometry.
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
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Measured as a percentage using spirometry.
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Maximum Voluntary Ventilation
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Measured in liters per minute using spirometry.
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Chest Wall Expansion at the Fourth Intercostal Space
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Chest wall expansion measured in centimeters using a non-elastic tape measure at the fourth intercostal space.
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Chest Wall Expansion at the Xiphoid Process Level
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Chest wall expansion measured in centimeters using a non-elastic tape measure at the level of the xiphoid process.
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Functional capacity
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
assessed by 6-Minute Walk Test (6MWT)
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
Change in Health-Related Quality of Life
Időkeret: Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).
using 36 Item Short Form Health Survey (SF 36) Health-related quality of life will be measured using the 36-Item Short Form Health Survey (SF-36). Scores for each domain and the Physical Component Summary (PCS) and Mental Component Summary (MCS) range from 0 to 100. Higher scores indicate better heal
Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Cairo University

Nyomozók

  • Tanulmányi szék: Mona A Abdelwahab, Assistant Prof, Cairo University
  • Tanulmányi igazgató: Shaimaa T Mohamed, Lecturer, Cairo University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. július 25.

Elsődleges befejezés (Becsült)

2026. december 15.

A tanulmány befejezése (Becsült)

2027. február 10.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 17.

Első közzététel (Tényleges)

2026. július 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 29.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 28.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CU-AA-19052026

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

Individual participant data will not be shared to maintain participant privacy and strictly adhere to confidentiality agreements.

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