Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability

NCT07734909 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of combining diaphragmatic strengthening with core stability exercises versus core stability exercises alone on recovery time, pain, and stability in lumbar instability individuals.

Conditions

Lumbar

Keywords

Diaphragm; Core; lumbar instability

Outcome Measures

Primary Outcomes (2)

• Pain intensity assessed using the Visual Analogue Scale (VAS)

  Pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  8 weeks

• Pressure pain threshold assessed by pressure algometry

  Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer. Higher values indicate reduced pain sensitivity.

  8 weeks

Secondary Outcomes (2)

• Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)

  8 weeks

• Functional disability assessed using the Oswestry Disability Index (ODI)

  8 weeks

Study Arms (2)

Combined diaphragm strengthening + Core stability exercises

EXPERIMENTAL

It will include patients that will perform combined diaphragm strengthening and core stability exercises. The treatment program will be 45 minutes, 3 times a week, for 8 weeks.

Other: Diaphragm strengthening; Other: Core stability exercises

Core stability exercises

ACTIVE COMPARATOR

It will include patients that will perform core stability exercises alone. The treatment program will be 45 minutes, 3 times a week, for 8 weeks.

Other: Core stability exercises

Interventions

Diaphragm strengthening OTHER

Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session). Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).

Combined diaphragm strengthening + Core stability exercises

Core stability exercises OTHER

Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session). The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks. Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.

Combined diaphragm strengthening + Core stability exercises; Core stability exercises

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 25 and 35 years.
• Positive prone instability test.
• Straight leg raising \>90 degrees.
• Pain assessment on VAS \>5/10.
• All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)

You may not qualify if:

• Patients with cardiovascular diseases.
• Patients with cerebrovascular diseases.
• Patients with neurological diseases.
• Patients with any attention disorders or physical disability.
• Patients with any diseases/conditions preventing physical activity participation.
• Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
• Patients with central obesity (A waist to hip ratio \>0.90 in males or \> 0.85 in females).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic of the faculty of physical therapy, Cairo University

Cairo, Egypt

Location

Study Officials

• Ahmad Mahdi Ahmad, PhD

  Professor, Cairo University

  STUDY CHAIR

• Maged Mohamed Samy Abouelsoud, PhD

  Professor, Ain Shams University

  STUDY DIRECTOR

• Mona AbdelRaouf Moursy

  Assist. Professor, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Hesham Abd El-Mawgoud, B.Sc

CONTACT

+20 11 20484750; ahmed.hesham.hassona@gmail.com

Mona AbdelRaouf Moursy, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

EG (1)