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

27. mars 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Eastren
      • Khobar, Eastren, Saudi-Arabia
        • King Fahd Hospital of the University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Andre navn:
  • Conventional physiotherapy- Hot packs, TENS
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in heart rate variability
Tidsramme: baseline and 6 weeks
heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF
baseline and 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart Rate Recovery
Tidsramme: 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
Tidsramme: baseline and after 6 weeks
Measurement of pain intensity
baseline and after 6 weeks
Oswestry Disability Index
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2018

Primær fullføring (Faktiske)

1. august 2019

Studiet fullført (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først innsendt

21. november 2018

Først innsendt som oppfylte QC-kriteriene

21. november 2018

Først lagt ut (Faktiske)

26. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB-PGS-2018-01-076

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No there is no plan to make the IPD available

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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