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Completed

NCT Number: NCT04055545

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

29 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT

Other
  • 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

MICT

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

Other names: moderate intensiv continuous training

Primary outcomes

  1. Adherence

    Time frame: 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 outcomes

  1. Enjoyability

    Time frame: 13 week

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

  2. Willingness to continue the training

    Time frame: 13 weeks

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

  3. Number of Adverse Events & Dropout rate

    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 outcomes

  1. Oswestry disability index

    Time frame: 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

    Time frame: 13 weeks

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

Sponsors and collaborators

Lead sponsor

Cerini Tamara

Other

Collaborators

  • Schulthess Klinik

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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