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

NCT03753165 | Completed

• 1 other identifier: IRB-PGS-2018-01-076
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain, Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Change in heart rate variability

  heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF

  baseline and 6 weeks

Secondary Outcomes (4)

• Heart Rate Recovery

  baseline and after 6 weeks

• Numerical pain scale

  baseline and after 6 weeks

• Oswestry Disability Index

  baseline and after 6 weeks

• Baroreceptor Sensitivity (BRS)

  baseline and 6 weeks

Study Arms (2)

High Intensity Interval Exercise group

EXPERIMENTAL

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

Other: High intensity interval exercise

Conventional physiotherapy

NO INTERVENTION

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

Interventions

High intensity interval exercise OTHER

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

Also known as: Conventional physiotherapy- Hot packs, TENS

High Intensity Interval Exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Khobar, Eastren, Saudi Arabia

Location

Related Publications (16)

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MeSH Terms

Interventions

High-Intensity Interval Training; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is a single blinded randomised clinical trial

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: October 30, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)