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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02911987
Date of registration:	13/09/2016
Prospective Registration:	No
Primary sponsor:	Hasselt University
Public title:	Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain LBP-HIT-RCT
Scientific title:	Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
Date of first enrolment:	August 2016
Target sample size:	125
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02911987
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Jonas Verbrugghe, drs.
Address:
Telephone:
Email:	jonas.verbrugghe@uhasselt.be
Affiliation:

Name:	Frank Vandenabeele, prof. dr.
Address:
Telephone:
Email:
Affiliation:	Hasselt University

Name:	Jonas Verbrugghe, drs.
Address:
Telephone:	+ 32 11 26 92 39
Email:	jonas.verbrugghe@uhasselt.be
Affiliation:

Name:	Annick Timmermans, prof. dr.
Address:
Telephone:
Email:
Affiliation:	Hasselt University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. medically diagnosed with non-specific chronic low back pain,

2. over 25 years old,

3. Oswestry Disability Index: disability score >20%,

4. able to understand Dutch (spoken and written),

5. Physical Activities Scale For Individuals with Physical Disabilities <30. -

Exclusion Criteria:

1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded,
microsurgery was allowed),

2. radiculopathy (uni- or bilateral),

3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes
mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of >
8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,

4. ongoing compensation claims and/or (work)disability > 6 months,

5. rehabilitation/exercise therapy program for LBP in the past 6 months. -

Age minimum: 25 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Low Back Pain

Intervention(s)

Other: moderate intensity training (MIT) exercise therapy

Other: high intensity training (HIT) program

Primary Outcome(s)

Abdominal/back strength [Time Frame: week 12]

pain [Time Frame: week 6]

Abdominal/back strength [Time Frame: day 1]

Abdominal/back strength [Time Frame: week 6]

Kinesiophobia [Time Frame: day 1]

Physical disability ODI [Time Frame: week 12]

Kinesiophobia [Time Frame: week 12]

Physical disability ODI [Time Frame: day 1]

Physical disability RMDQ [Time Frame: week 12]

activity level [Time Frame: week 12]

activity level [Time Frame: week 6]

Physical disability RMDQ [Time Frame: day 1]

Endurance capacity [Time Frame: day 1]

Muscle Biopsy [Time Frame: week 12]

Physical disability RMDQ [Time Frame: week 6]

activity level [Time Frame: day 1]

Kinesiophobia [Time Frame: week 6]

Endurance capacity [Time Frame: week 12]

Endurance capacity [Time Frame: week 6]

Muscle Biopsy [Time Frame: day 1]

pain [Time Frame: week 12]

pain [Time Frame: day 1]

Physical disability ODI [Time Frame: week 6]

Secondary Outcome(s)

disability in participation and quality of life [Time Frame: week 12]

Motivation IMI [Time Frame: week 12]

Body composition [Time Frame: day 1]

Body composition [Time Frame: week 12]

Body composition [Time Frame: week 6]

disability in participation and quality of life [Time Frame: week 6]

Motivation IMI [Time Frame: day 1]

disability in participation and quality of life [Time Frame: day 1]

Motivation VAS [Time Frame: day 1]

physical activity tracking [Time Frame: week 12]

Motivation VAS [Time Frame: week 12]

physical activity tracking [Time Frame: day 1]

Motivation IMI [Time Frame: week 6]

Motivation VAS [Time Frame: week 6]

Secondary ID(s)

LBP-HIT-RCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jessa Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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