CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
High intensity interval exerciseother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03753165
NCT03753165N/ACompleted

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

Imam Abdulrahman Bin Faisal University·interventional·Posted Nov 26, 2018·Updated Mar 30, 2020

In Brief

A clinical study evaluating High intensity interval exercise for Chronic Low Back Pain. Completed, enrolled 80 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 26, 2018
Enrollment StartSep 1, 2018
Primary CompletionAug 1, 2019
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.6 years ago

Interventions

High intensity interval exerciseother

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