NCT07718178

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

July 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 14, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Forced Vital Capacity

    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

    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

    Measured as a percentage using spirometry.

    Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).

  • Maximum Voluntary Ventilation

    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

    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

    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).

Secondary Outcomes (2)

  • Functional capacity

    Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).

  • Change in Health-Related Quality of Life

    Baseline (pre-intervention) and at the end of the 8-week training period (post-intervention).

Study Arms (2)

Mulligan Thoracic Mobilization

EXPERIMENTAL

will receive Mulligan thoracic mobilization in extension five times per week for 8 weeks in addition to a standardized diet and aerobic exercise.

Procedure: Mulligan Thoracic MobilizationBehavioral: low carbohydrateBehavioral: Aerobic Exercise

low carbohydrate and Aerobic Exercises

ACTIVE COMPARATOR

will receive standardized diet and aerobic exercise.

Behavioral: low carbohydrateBehavioral: Aerobic Exercise

Interventions

Standardized low-carbohydrate dietary program administered for 8 weeks.

Mulligan Thoracic Mobilizationlow carbohydrate and Aerobic Exercises

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.

Mulligan Thoracic Mobilizationlow carbohydrate and Aerobic Exercises

* 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.

Mulligan Thoracic Mobilization

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mona A Abdelwahab, Assistant Prof

    Cairo University

    STUDY CHAIR
  • Shaimaa T Mohamed, Lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Abd El-Rahman A Abd El-Monem

CONTACT

Alaa N Abdelhameed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 21, 2026

Study Start

July 25, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

February 10, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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