Exercise Interventions for Overweight Men With Chronic Low Back Pain

ConditionsNon-specific Chronic Low Back Pain Central Sensitization

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-59

SponsorUniversiti Sains Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.
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.

Treatment groups

156 Participants

are divided into 4 treatment groups

Group A: Motor Control Exercise Plus EducationExperimental treatment 1 intervention

Group B: Aerobic Walking Exercise Plus EducationExperimental treatment 1 intervention

Group C: Muscle Strengthening Exercise Plus EducationExperimental treatment 1 intervention

Group D: Patient Education OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame