High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: HIIT; Other: MICT

• Registration Number: NCT04055545
• Lead Sponsor: Cerini Tamara

Brief Summary

The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.

Detailed Description

The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.

However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.

In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.

Study Timeline

• Study First Submitted: 2019-08-10
• Study First Submitted QC: 2019-08-10
• Study First Posted: 2019-08-13
• Study Start: 2019-09-25
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Oswestry disability index (ODI) Score ≥ 14%
• Low back pain for at least 3 months.
• Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
• Good understanding of German or English, written and spoken.
• Age between 29 - 69
• No or stopped physical therapy.

Exclusion Criteria

• Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
• Known pregnancy.
• Previous low back spinal surgery in the last 2 years.
• Tumour, spinal stenosis, spinal fractures or radiculopathy.
• Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIIT	HIIT	-
MICT	MICT	-

Primary Outcome Measures

Name	Time	Method
Adherence	13 weeks	Difference in training adherence rate between HIIT and MICT. The adherence rate will be calculated in the amount of days a patient trained versus the total days they were scheduled to train.

Secondary Outcome Measures

Name	Time	Method
Enjoyability	13 week	Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it.
Number of Adverse Events & Dropout rate	13 weeks	Dropout rate and adverse events connected with the training
Recruited rate	3 months	Screened patients in relation with the number of recruited patients
Willingness to continue the training	13 weeks	Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high.

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland