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Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients (CLBP)

27 mars 2020 mis à jour par: Haya Mohammad ALMaawi, Imam Abdulrahman Bin Faisal University

Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients

Patients with low back pain (LBP) often report an overall reduced physical activity and fitness that could consequently lead to an altered autonomic balance. Dysregulation of autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation and persistence of chronic muscle pain.High intensity interval exercise (HIIE) is a newer modality where short bursts of high intensity exercise are interspersed with rest intervals.

Method:Study Design: It is a single blinded randomised clinical trial.Sample Size:

Experimental Group (HIIE+ standard regular physiotherapy) = 40 Positive Control Group (standard regular physiotherapy) = 40 After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, eighty (80) patients with nonspecific CLBP (either sex, age range 18-65 years years) will be recruited. These patients, with mild to moderate disability/pain according to Oswestry index, will be referred from the orthopedics clinic, rheumatologist, neurology, rehabilitation specialist, to the physiotherapy department.

Oswestry Disability Index (ODI) will be completed for all CLBP patients. Pre and post assessment includes pain intensity, disability, resting heart rate (HRrest) and blood pressure, maximum heart rate (HRmax) after graded maximal exercise, heart rate recovery after graded maximal exercise (HRR).

Tests of autonomic function will be done by recording ECG and analyzing he ECG for variability in heart rate (HRV), the Expiratory/inspiratory ratio in deep breathing (HRVdb) and baroreceptor sensitivity (BRS) at rest. Additionally each subject will be exposed to an orthostatic challenge and his responses will be evaluated. The recording will be done first in supine position and then asking the patient to quickly stand up and remain standing for 5 min. Data will be entered in Microsoft excel and comparisons and correlations will be done using either excel or SPSS version 20.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Effect of High Intensity Interval Exercise on pain, disability and autonomic balance in patients with chronic low back pain

Chronic low back pain (CLBP) is a clinical problem of large magnitude with great socio-economical effect. About 80% of people may complain of low back pain in their life.

Patients with low back pain (LBP) often report an overall reduced physical activity and fitness that could consequently lead to an altered autonomic balance. Dysregulation of autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation and persistence of chronic muscle pain. Different types of exercises can be prescribed to patients with CLBP to improve pain, disability and physical fitness. High intensity interval exercise (HIIE) is a newer modality where short bursts of high intensity exercise are interspersed with rest intervals.it is more time efficient, enjoyable, and superior to mild or moderate intensity continuous exercise in improving the physical fitness, peak performance, autonomic balance, muscle strength and coordination in athletes. HIIE might prove more useful and effective for individuals with nonspecific CLBP and could have a better adherence rate in the long run.

Methods: After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, KSA, eighty (80) patients with nonspecific CLBP (either sex, age: 18-65 years) will be recruited. These patients, with mild to moderate disability/pain according to Oswestry index, will be referred from relevant clinics to the physiotherapy department of King Fahd Hospital of the University, AlKhobar (KFHU). After full explanation of the study, the patients will be required to sign an informed consent form and then they will be randomly assigned to one of the two groups.

Experimental Group (GE: n= 40) will be assigned for HIIE in addition to standard regular physiotherapy, and Control Group (GC: n=40) will be designated as control group with standard regular physiotherapy only. Pre and post intervention assessment includes pain intensity through Numerical Pain Scale, disability through Oswestry Disability Index (ODI) and autonomic balance through heart rate variability (HRV) and baroreflex sensitivity (BRS) at rest and in response to an orthostatic challenge.

Data will be entered in Microsoft excel and comparisons and correlations will be done using either excel or SPSS version 20 Expectations: It is expected that HIIE will improve the autonomic balance of the CLBP patients to a greater extent compared to no-exercise and consequently improve the pain and disability to a higher degree. HIIE could be a useful, efficacious addition to the list of exercise modalities for patients with nonspecific CLBP, and could be recommended for management of appropriate group of CLBP patients.

Type d'étude

Interventionnel

Inscription (Réel)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Eastren
      • Khobar, Eastren, Arabie Saoudite
        • King Fahd Hospital of the University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age range 18-65 years.
  • BMI 18.5 - 34.9 kg/m2.
  • Diagnosed patients as non-specific chronic low back pain patients, referred by orthopedic specialist, rheumatologist, rehabilitation specialist to physical therapy.
  • Oswestry Disability Index (ODI): mild to moderate .
  • The subjects should be able to understand, communicate and perform the examination and can walk without any walking aids.

Exclusion Criteria:

  • Walking with using any walking aids.
  • Subjects with secondary LBP, Sciatica, Osteoporosis, Osteoarthritis, generalized neuromuscular problem or any deformity.
  • Any diagnosed disease likely to interfere with exercise on bicycle ergometer or safety of the subject (especially cardiac or respiratory disease.
  • Patients with known diabetic autonomic complications
  • Persons taking medicines that are known to interfere with HRV variables, such as beta blockers, calcium antagonists.
  • Pregnancy or lactation.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: High Intensity Interval Exercise group
Patients suffering from chronic low back pain perform 12 sessions of high intensity interval exercise (HIIE) over a period of 6 weeks at an intensity of 80% of their maximal Heart rate. In addition they also receive conventional physiotherapy in the form of hot pack or TENS
High intensity interval exercise at 80% of the maximal heart rate derived from the maximal graded exercise. Each individual will undergo 12 sessions of HIIE over a period of six weeks
Autres noms:
  • Conventional physiotherapy- Hot packs, TENS
Aucune intervention: Conventional physiotherapy
Patients suffering from chronic low back pain will receive conventional physiotherapy such as TENS and hot packs applied over appropriate areas over a period of 6 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in heart rate variability
Délai: baseline and 6 weeks
heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF
baseline and 6 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Heart Rate Recovery
Délai: baseline and after 6 weeks
Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise
baseline and after 6 weeks
Numerical pain scale
Délai: baseline and after 6 weeks
Measurement of pain intensity
baseline and after 6 weeks
Oswestry Disability Index
Délai: baseline and after 6 weeks
Questionnaire to assess the disability in patients with chronic low back pain
baseline and after 6 weeks
Baroreceptor Sensitivity (BRS)
Délai: baseline and 6 weeks
recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS
baseline and 6 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2018

Achèvement primaire (Réel)

1 août 2019

Achèvement de l'étude (Réel)

30 octobre 2019

Dates d'inscription aux études

Première soumission

21 novembre 2018

Première soumission répondant aux critères de contrôle qualité

21 novembre 2018

Première publication (Réel)

26 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mars 2020

Dernière vérification

1 mars 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-PGS-2018-01-076

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No there is no plan to make the IPD available

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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