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

Study Overview
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Brief Summary
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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
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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.

Official Title
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12 Week High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects: a Randomized Single-blinded Feasibility Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: HIIT
* Other: MICT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MICT<br> | Other: MICT<br>* 5 min. warm up 20 min. continuous cycling: HRR btw. 40% - 59% 5 min. cool down<br>* Other names: moderate intensiv continuous training;|
| Active Comparator: HIIT<br> | Other: HIIT<br>* 5 min. warm up 10 × 60 seconds burst 60 seconds recovery after each burst Burst phase: HRR >90% Recovery phase: HRR btw. 30-39% 5 min. cool down<br>* Other names: high intensity interval training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | 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. | 13 weeks | 

Secondary Outcome Measures

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