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

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ClinicalTrials.gov Identifier: NCT04055545
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Schulthess Klinik
Information provided by (Responsible Party):
Cerini Tamara, HES-SO Valais-Wallis

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
Low Back Pain Other: HIIT Other: MICT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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 Name: high intensity interval training




Primary Outcome Measures :
  1. Adherence [ Time Frame: 13 weeks ]
    Difference in training adherence rate (after 12 weeks training program) between HIIT and MICT


Secondary Outcome Measures :
  1. Enjoyability [ Time Frame: 13 week ]
    Scale from -3 to +3

  2. Willingness to continue the training [ Time Frame: 13 weeks ]
    Scale from -3 to +3

  3. AE & SAE [ Time Frame: 13 weeks ]
    Dropout rate and adverse events connected with the training

  4. recruited rate [ Time Frame: 3 months ]
    Screened patients in relation with the number of recruited patients


Other Outcome Measures:
  1. ODI [ Time Frame: 13 weeks ]
    Oswestry low back pain disability questionnaire

  2. NPRS [ Time Frame: 13 weeks ]
    Numeric Pain Rate Scale



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Ages Eligible for Study:   29 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055545


Contacts
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Contact: Tamara Cerini, Bsc +41 44 385 75 50 tamara.cerini@kws.ch

Locations
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Switzerland
Schulthess Klinik Recruiting
Zürich, Switzerland, 8008
Contact: Tamara Cerini, Bsc    +41 44 385 75 50    tamara.cerini@kws.ch   
Sponsors and Collaborators
Cerini Tamara
Schulthess Klinik

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Responsible Party: Cerini Tamara, Bsc, HES-SO Valais-Wallis
ClinicalTrials.gov Identifier: NCT04055545     History of Changes
Other Study ID Numbers: HIITvsMICT
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms