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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055545
• Other study ID #: HIITvsMICT
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2020
• Source: HES-SO Valais-Wallis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• HIIT
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
• MICT
5 min. warm up 20 min. continuous cycling: HRR btw. 40% - 59% 5 min. cool down

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Cerini Tamara	Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oswestry disability index	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%.	13 weeks
Other	Numeric Pain Rate Scale	Pain score from 0 to 10. 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain.	13 weeks
Primary	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	Enjoyability	Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it.	13 week
Secondary	Willingness to continue the training	Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high.	13 weeks
Secondary	Number of Adverse Events & Dropout rate	Dropout rate and adverse events connected with the training	13 weeks
Secondary	Recruited rate	Screened patients in relation with the number of recruited patients	3 months