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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

HIIT

MICT

About this trial

This is an interventional other trial for Low Back Pain

Eligibility Criteria

29 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Schulthess Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MICT

HIIT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Enjoyability

Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it.

Willingness to continue the training

Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high.

Number of Adverse Events & Dropout rate

Dropout rate and adverse events connected with the training

Recruited rate

Screened patients in relation with the number of recruited patients

Full Information

NCT ID

NCT04055545

First Posted

August 10, 2019

Last Updated

April 12, 2020

Sponsor

Cerini Tamara

Collaborators

Schulthess Klinik

1. Study Identification

Unique Protocol Identification Number

NCT04055545

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 25, 2019 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cerini Tamara

Collaborators

Schulthess Klinik

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MICT

Arm Type

Active Comparator

Arm Title

HIIT

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

HIIT

Other Intervention Name(s)

high intensity interval training

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

MICT

Other Intervention Name(s)

moderate intensiv continuous training

Intervention Description

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

Primary Outcome Measure Information:

Title

Adherence

Description

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.

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Enjoyability

Description

Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it.

Time Frame

13 week

Title

Willingness to continue the training

Description

Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high.

Time Frame

13 weeks

Title

Number of Adverse Events & Dropout rate

Description

Dropout rate and adverse events connected with the training

Time Frame

13 weeks

Title

Recruited rate

Description

Screened patients in relation with the number of recruited patients

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Oswestry disability index

Description

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%.

Time Frame

13 weeks

Title

Numeric Pain Rate Scale

Description

Pain score from 0 to 10. 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain.

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

29 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Schulthess Klinik

City

Zürich

ZIP/Postal Code

8008

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35491417

Citation

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.

Results Reference

derived

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

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