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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: MICT; Other: HIIT

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MICT	Other: MICT; 5 min. warm up; 20 min. continuous cycling: HRR btw. 40% - 59%; 5 min. cool down; Other Names: moderate intensiv continuous training
Active Comparator: HIIT	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; Other Names: high intensity interval training

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Numeric Pain Rate Scale	Pain score from 0 to 10. 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain.	13 weeks

Collaborators and Investigators

• Sponsor: Cerini Tamara
• Collaborators: Schulthess Klinik

Publications and helpful links

General Publications

• Cerini T, Hilfiker R, Riegler TF, Felsch QTM. 12 weeks high intensity interval training versus moderate intensity continuous training in chronic low back pain subjects: a randomised single-blinded feasibility study. Arch Physiother. 2022 May 2;12(1):12. doi: 10.1186/s40945-022-00136-3.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HIITvsMICT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No