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Exercise Interventions for Overweight Men With Chronic Low Back Pain (MAMS-CLBP)

30 de junho de 2026 atualizado por: Mohammad Abdel Rahman Mohammad Jarrar, Universiti Sains Malaysia

Effectiveness of Motor Control, Aerobic Walking, and Muscle Strengthening Exercises in Improving Outcomes in Overweight Male Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Chronic non-specific low back pain (CNSLBP) is a leading cause of disability worldwide and is frequently associated with impaired pain modulation, reduced physical function, and diminished quality of life. Overweight individuals may be at increased risk of persistent low back pain due to increased mechanical loading, reduced physical fitness, and alterations in pain processing. Central sensitization has been identified as an important mechanism contributing to persistent symptoms in a subgroup of individuals with chronic low back pain.

Exercise therapy is recommended as a first-line treatment for CNSLBP; however, uncertainty remains regarding the comparative effectiveness of different exercise approaches in overweight individuals with central sensitization. Motor control exercise aims to improve the activation and coordination of deep trunk stabilizing muscles. Aerobic walking exercise may improve physical fitness and pain modulation. Muscle strengthening exercise is intended to enhance muscular strength and functional performance. Additional evidence is needed to determine which exercise strategy provides the greatest clinical benefit in this population.

This study is an assessor-blinded, four-arm, parallel-group randomized controlled trial. A total of 156 overweight male adults with non-specific chronic low back pain and evidence of central sensitization will be recruited and randomly allocated 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. Interventions will be delivered over a 12-week period with supervised sessions conducted twice weekly.

The primary objective is to compare the effects of the interventions on conditioned pain modulation as an indicator of endogenous pain inhibitory function. Secondary objectives are to evaluate changes in pain intensity, disability, health-related quality of life, executive function, and isometric trunk muscle strength. Body weight and body mass index will also be explored as additional variables of interest.

Outcome assessments will be performed at baseline, immediately following completion of the intervention period, and at 6-month follow-up. The findings of this trial are expected to provide evidence regarding the comparative effectiveness of commonly prescribed exercise interventions for improving pain modulation and clinical outcomes in overweight men with chronic non-specific low back pain and central sensitization.

Tipo de estudo

Intervencional

Inscrição (Estimado)

156

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Mohammad AbdlRahman Jarrar, Master of Sciences
  • Número de telefone: Mohammad KSA. 00966502764110
  • E-mail: jarrar@studen.usm.my

Locais de estudo

  • Arábia Saudita
    • Najran Region
      • Najran, Najran Region, Arábia Saudita, 61441
        • Physiotherapy Clinic at the College of Applied Medical Sciences, Najran University, Najran City, Saudi Arabia.
        • Contato:
          • Mohammad AbdlRahman Jarrar, Master of Sciences
          • Número de telefone: KSA. 00966502764110
          • E-mail: jarrar@student.usm.my
        • Contato:
        • Investigador principal:
          • Mohammad AbdlRahman Jarrar, Master of Sciences
        • Subinvestigador:
          • Dr Eva NABIHA BINTI ZAMRI, PhD, PUBLIC HEALTH
        • Subinvestigador:
          • DR. HAZWANI AHMAD USOF@HANAFI, PhD Health Sciences

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Motor Control Exercise Plus Education
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).
Comportamental: Motor Control Exercise
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.
Experimental: Aerobic Walking Exercise Plus Education
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).
Comportamental: Aerobic Walking Exercise
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.
Experimental: Muscle Strengthening Exercise Plus Education
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).
Comportamental: Muscle Strengthening Exercise
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.
Comparador Ativo: Patient Education Only
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.
Comportamental: Patient Education
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Conditioned Pain Modulation (CPM)
Prazo: Baseline, 12 weeks, and 6 months after intervention
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pain Intensity
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS). Scores range from 0 to 10 points, with higher scores indicating greater pain intensity.
Baseline, 12 weeks, and 6 months after intervention
Disability
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in disability measured using the Oswestry Disability Index (ODI). Scores range from 0 to 100 points, with higher scores indicating greater disability related to low back pain.
Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Physical Domain
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in physical health-related quality of life measured using the WHOQOL-BREF Physical domain. Scores range from 0 to 100, with higher scores indicating better physical quality of life.
Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Psychological Domain
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in psychological health-related quality of life measured using the WHOQOL-BREF Psychological domain. Scores range from 0 to 100, with higher scores indicating better psychological quality of life.
Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Social Relationships Domain
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in social relationships measured using the WHOQOL-BREF Social Relationships domain. Scores range from 0 to 100, with higher scores indicating better social quality of life.
Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Environment Domain
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in environmental quality of life measured using the WHOQOL-BREF Environment domain. Scores range from 0 to 100, with higher scores indicating better environmental quality of life.
Baseline, 12 weeks, and 6 months after intervention
Working Memory
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in working memory measured using the Letter-Number Sequencing Test. The outcome will be reported as the total test score, with higher scores indicating better working memory performance.
Baseline, 12 weeks, and 6 months after intervention
Executive Function
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in executive function measured using the Stroop Color-Word Test. The outcome will be reported as the Stroop interference score, with higher scores indicating poorer inhibitory control and cognitive flexibility.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Flexion Strength
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric trunk flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater trunk flexion muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Extension Strength
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric trunk extension strength measured using the DIERS myoline system. Higher peak force values indicate greater trunk extension muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Lateral Flexion Strength - Right
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric right trunk lateral flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Lateral Flexion Strength - Left
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric left trunk lateral flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Rotation Strength - Right
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric right trunk rotation strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Rotation Strength - Left
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in peak isometric left trunk rotation strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Baseline, 12 weeks, and 6 months after intervention
Body Weight
Prazo: Baseline, 12 weeks, and 6 months after intervention
Change in body weight measured using a calibrated digital scale and reported in kilograms (kg).
Baseline, 12 weeks, and 6 months after intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universiti Sains Malaysia

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de julho de 2026

Conclusão Primária (Estimado)

5 de novembro de 2026

Conclusão do estudo (Estimado)

5 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de junho de 2026

Primeira postagem (Real)

7 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

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Outros números de identificação do estudo

  • HAPO-11-N-102-02604-076-043941 (Outro identificador: NU Research Ethics Committee)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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