Low Back Pain
Conditions
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.
Interventions
OTHERHIIT
* 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
OTHERMICT
* 5 min. warm up * 20 min. continuous cycling: HRR btw. 40% - 59% * 5 min. cool down
Sponsors
Schulthess Klinik
Cerini Tamara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
29 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Enjoyability | 13 week | Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it. |
| Willingness to continue the training | 13 weeks | Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oswestry disability index | 13 weeks | The Oswestry low back pain disability questionnaire examines the perceived level of disability in the everyday activities of daily living. 0% to 20% = Minimal disability; 21% to 40% = Moderate disability; 41% to 60% = Severe disability; 61% to 80% = crippled; 81% to 100%. |
| Numeric Pain Rate Scale | 13 weeks | Pain score from 0 to 10. 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. |
Countries
Switzerland
Outcome results
None listed