Aalborg University
Gistrup, 9260, Denmark
NCT Number: NCT06594731
The purpose of this project is to investigate the feasibility of using belt squat as an exercise intervention for people with chronic low back pain. We will recruit people with chronic low back pain as well as asymptomatic controls
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Gistrup, 9260, Denmark
The purpose of the current project is to evaluate the feasibility of performing belt squats in healthy participants and persistent non-specific low back pain (LBP) patients.
For this project we wish to recruit 20 healthy volunteers 20 volunteers LBP patients through notices at Aalborg University, on www.forsog.dk, and on Facebook. The following inclusion and exclusion criteria will be used for the healthy subjects:
Healthy men and women, age 18-60.
And for the LBP patients:
Non-specific LBP for more than twelve weeks without major sciatica (back pain >leg pain), age 18-60.
Exclusion criteria
pertinent to all subjects were:
Leg pain greater than back pain, neuromuscular disorders, spinal or lower extremity fractures, infections, cancer, osteoporosis, dementia, BMI>35, current substance abuse, former lumbar surgery, persistent pain syndromes other than back pain, inflammatory rheumatic diseases.
In the study, participants will perform hip belt squat training twice per week for 6 weeks.
To test the feasibility of performing hip belt squat training in healthy participants and persistent LBP patients the project will be based on the Bowen feasibility model. This model lists eight different focus areas for feasibility studies, where this particular sub-project will focus on four of these areas being: acceptability, demand, implementation, and practicality.
To test the acceptability and demand, subjects will be interviewed on their satisfaction, intention to continue use, actual use, perceived appropriateness, and perceived demand of the training.
Implementation and practicality will be assessed by evaluation of the degree of execution, success or failure of execution, factors affecting implementation ease or difficulty, positive/negative effects on participants, ability of participants to carry out the training activities and a cost analysis.
Lastly, to test the acceptance of methods relevant to the training, measures on lumbar flexibility, muscle strength, muscle mass (DEXA scan), pain sensitivity (pressure-pain threshold, PPT) using a handheld pressure algometer (Somedic, Sweden), muscle activity (Electromyographic measurement, EMG) and the following questionnaires: Fear-avoidance Beliefs Questionnaire (FABQ), Oswestry Disability Index (ODI) (which ranges from 0 (no disability) to 100 (bedridden)), health-related quality of life as measured by EuroQOL-5D (EQ-5D) (ranging from -0.596 to 1, with higher scores indicating better quality of life) will be carried out
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hip belt squat training performed twice per week for 6 weeks
Time frame: Immediately after the intervention
Acceptability of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was acceptable or not.
Time frame: Immediately after the intervention
Demand of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the participants wish to incorporate belt squats into their future training.
Time frame: Immediately after the intervention
Implementation of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was feasible or not.
Time frame: Immediately after the intervention
Practicality will be assessed by evaluation of the adherence level, computed as the percentage of completed training sessions.
Time frame: Assessed at baseline and immediately after the intervention period
Pressure-pain threshold was assessed using a handheld pressure algometer.
Time frame: Assessed at baseline and immediately after the intervention period
Muscle strength was assessed in the hop belt squat exercise using a 5 repetition maximum test
Time frame: Assessed at baseline and immediately after the intervention period
Lumbar flexibility was assessed using a custom made test.
Time frame: Assessed at baseline and immediately after the intervention period
Electromyography was used to assess muscle activation.
Time frame: Assessed at baseline and immediately after the intervention period
A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden).
Time frame: Assessed at baseline and immediately after the intervention period
A questionnaire measuring the easured health-related quality of life (EuroQOL-5D), ranging from -0.596 to 1, with higher scores indicating better quality of life.
Time frame: Assessed at baseline and immediately after the intervention period
Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief.
Time frame: Assessed at baseline and immediately after the intervention period
To assess changes in body composition a DEXA scan was performed. This test quantified lean body mass (kg) and fat mass (kg).
Mathias Kristiansen
Other
Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study
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.
Published trials that share one or more normalized conditions with this study.
NCT06840795
Back Pain, Low Back Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06843785
Back Pain, Balance; Distorted
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06837753
Back Pain, Low Back Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06787079
Back Pain, Behavior
Ankara, Turkey (Türkiye)
View Trial Details