Exercise Interventions for Overweight Men With Chronic Low Back Pain

NCT07688564 | Not Yet Recruiting

• 1 other identifier: HAPO-11-N-102-02604-076-043941
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effectiveness of motor control exercise, aerobic walking exercise, and muscle strengthening exercise in overweight male adults with non-specific chronic low back pain and central sensitization. A total of 156 participants will be randomly assigned to one of four groups: motor control exercise plus patient education, aerobic walking exercise plus patient education, muscle strengthening exercise plus patient education, or patient education only. The interventions will be delivered over 12 weeks. The primary outcome is conditioned pain modulation (CPM), which reflects endogenous pain inhibitory function. Secondary outcomes include pain intensity, disability, health-related quality of life, executive function, and isometric trunk muscle strength. Body weight and body mass index will also be assessed as exploratory variables. Outcomes will be evaluated at baseline, immediately after the 12-week intervention, and at 6-month follow-up.

Conditions

Central Sensitization; Non-specific Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Non-Specific Chronic Low Back Pain; Central Sensitization; Conditioned Pain Modulation; Motor Control Exercise; Aerobic Walking; Muscle Strengthening Exercise; Exercise Therapy; Overweight; Pain Modulation; Trunk Muscle Strength; Executive Function; Physical Therapy; Physiotherapy; Rehabilitation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Conditioned Pain Modulation (CPM)

  Conditioned pain modulation (CPM), assessed using the Cold Pressor Test. CPM will be quantified using pressure pain threshold (PPT) measurements obtained before and after the conditioning stimulus. Higher CPM values indicate more effective endogenous pain inhibitory function.

  Baseline, 12 weeks, and 6 months after intervention

Secondary Outcomes (15)

• Pain Intensity

  Baseline, 12 weeks, and 6 months after intervention

• Disability

  Baseline, 12 weeks, and 6 months after intervention

• Health-Related Quality of Life - Physical Domain

  Baseline, 12 weeks, and 6 months after intervention

• Health-Related Quality of Life - Psychological Domain

  Baseline, 12 weeks, and 6 months after intervention

• Health-Related Quality of Life - Social Relationships Domain

  Baseline, 12 weeks, and 6 months after intervention

Study Arms (4)

Motor Control Exercise Plus Education

EXPERIMENTAL

Participants will receive a supervised motor control exercise program combined with patient education. The intervention is designed to improve activation, coordination, and control of the deep trunk stabilizing muscles. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).

Behavioral: Motor Control Exercise

Aerobic Walking Exercise Plus Education

EXPERIMENTAL

Participants will receive a supervised moderate-intensity aerobic walking program combined with patient education. The intervention aims to improve physical fitness and endogenous pain modulation. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).

Behavioral: Aerobic Walking Exercise

Muscle Strengthening Exercise Plus Education

EXPERIMENTAL

Participants will receive a supervised progressive muscle strengthening exercise program combined with patient education. The program targets trunk and lower-extremity muscles to improve strength and functional performance. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).

Behavioral: Muscle Strengthening Exercise

Patient Education Only

ACTIVE COMPARATOR

Participants will receive a standardized patient education program focusing on chronic low back pain self-management, physical activity, posture, and healthy lifestyle recommendations. Participants will attend two sessions per week for 12 weeks.

Behavioral: Patient Education

Interventions

Motor Control Exercise BEHAVIORAL

A supervised motor control exercise program targeting deep trunk stabilizing muscles (Motor control exercises (drawing-in, multifidus, bridging, quadruped). The program focuses on improving muscle activation, coordination, and motor control during functional tasks. Sessions will be delivered twice weekly for 12 weeks under physiotherapist supervision.

Motor Control Exercise Plus Education

Aerobic Walking Exercise BEHAVIORAL

A supervised moderate-intensity aerobic walking program designed to improve cardiovascular fitness and enhance endogenous pain inhibitory mechanisms. (5-min warm-up (treadmill) + 20-40 min moderate walking + 5-min cool-down + 30s stretching). Participants will perform structured walking sessions twice weekly for 12 weeks, monitored by a physiotherapist.

Aerobic Walking Exercise Plus Education

Muscle Strengthening Exercise BEHAVIORAL

A supervised progressive resistance training program targeting trunk and lower limb muscles. Exercises will focus on improving muscular strength, endurance, and functional capacity. (Rectus abdominis, obliques (OI/OE), erector spinae: curl-ups, side planks, bird dog, prone extension). The program will be delivered twice weekly for 12 weeks under physiotherapist supervision.

Muscle Strengthening Exercise Plus Education

Patient Education BEHAVIORAL

A structured educational program covering chronic low back pain mechanisms, posture correction, physical activity guidance, and self-management strategies. (Health education lectures + 10-min discussion: pain neuroscience, posture, self-management) Education will be delivered throughout the 12-week intervention period.

Patient Education Only

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged ≥ 18 to \< 60 years.
• Diagnosed with nonspecific CLBP that has persisted for over three months.
• Overweight males (not obese), with a BMI between 25.0 and 29.9 kg/m² (the standard WHO/CDC classification). Excludes normal weight (\<25 kg/m²) and obesity (≥30 kg/m²) to focus on the mechanical and metabolic consequences of excess weight and to avoid confounding by significant comorbidities, mobility restrictions, or modified exercise tolerance that may skew CPM results.
• Pain level greater than 4 on the Numerical Pain Rating Scale (NPRS).
• Signs and symptoms indicating that a CS measurement is required must be present, with a CSI score of 40 or higher.
• Psychological status will be screened with the Depression Anxiety Stress Scales-21 (DASS-21) to confirm the absence of clinically significant symptoms of depression, anxiety, or stress. Eligible participants will be overweight males aged 18 to 60 years with nonspecific CLBP who score within the normal range on all DASS-21 subscales. Participants with severe psychological distress will be excluded, while mild to moderate symptoms will be statistically controlled.

You may not qualify if:

• CLBP due to a recognized specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, or inflammatory disorders such as ankylosing spondylitis, radiculopathy, or cauda equina syndrome).
• Contraindications for physical activity participation.
• A history of spine surgery or spine diseases that cause symptoms.
• The presence of acute pain within 48 hours prior to the study date.
• A history of using corticosteroids or other pain-affecting medications within the past two weeks is also required.
• Participants must not have other long-term pain conditions, high blood pressure, Raynaud's disease, frostbite, open wounds, broken bones, serious illnesses such as cancer, or mental health problems.
• Visual and/or hearing impairments. These criteria apply uniformly to all four study arms: MCE, AW, MSE, and the patient education (control) arm.
• These specific criteria ensure that the study group is homogeneous, which is important for examining how exercise interventions affect overweight males with nonspecific CLBP who exhibit central sensitization.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Physiotherapy Clinic at the College of Applied Medical Sciences, Najran University, Najran City, Saudi Arabia.

Najran, Najran Region, 61441, Saudi Arabia

Location

MeSH Terms

Conditions

Overweight

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Mohammad AbdlRahman Jarrar, Master of Sciences

CONTACT

KSA. 00966502764110; jarrar@studen.usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the exercise interventions, participants and treating therapists cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate and Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: (1) motor control exercise, (2) aerobic walking exercise, (3) muscle strengthening exercise, or (4) a patient education control group. Each intervention will be delivered for 12 weeks.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: July 5, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): April 5, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

SA (1)