NCT04055545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

August 10, 2019

Last Update Submit

April 12, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Enjoyability

    13 week

  • Willingness to continue the training

    13 weeks

  • Number of Adverse Events & Dropout rate

    13 weeks

  • Recruited rate

    3 months

Other Outcomes (2)

  • Oswestry disability index

    13 weeks

  • Numeric Pain Rate Scale

    13 weeks

Study Arms (2)

MICT

ACTIVE COMPARATOR
Other: MICT

HIIT

ACTIVE COMPARATOR
Other: HIIT

Interventions

HIITOTHER

* 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

Also known as: high intensity interval training
HIIT
MICTOTHER

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

Also known as: moderate intensiv continuous training
MICT

Eligibility Criteria

Age29 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 35491417DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

August 10, 2019

First Posted

August 13, 2019

Study Start

September 25, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)