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

Sponsor
Cerini Tamara (Other)
Overall Status
Completed
CT.gov ID
NCT04055545
Collaborator
Schulthess Klinik (Other)
30
Enrollment
1
Location
2
Arms
5.6
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HIIT
  • Other: MICT
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
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
Actual Study Start Date :
Sep 25, 2019
Actual Primary Completion Date :
Mar 13, 2020
Actual Study Completion Date :
Mar 13, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Enjoyability [13 week]

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

    2. Willingness to continue the training [13 weeks]

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

    3. Number of Adverse Events & Dropout rate [13 weeks]

      Dropout rate and adverse events connected with the training

    4. Recruited rate [3 months]

      Screened patients in relation with the number of recruited patients

    Other Outcome Measures

    1. 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%.

    2. Numeric Pain Rate Scale [13 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schulthess Klinik Zürich Switzerland 8008

    Sponsors and Collaborators

    • Cerini Tamara
    • Schulthess Klinik

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cerini Tamara, Sponsor-Investigator, HES-SO Valais-Wallis
    ClinicalTrials.gov Identifier:
    NCT04055545
    Other Study ID Numbers:
    • HIITvsMICT
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Apr 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Apr 14, 2020