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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low back pain patients | Experimental | Low back pain subjects performing hip belt squat training twice per week for 6 weeks. |
|
| Healthy individuals | Active Comparator | Healthy individuals performing hip belt squat training twice per week for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip belt squat training | Other | Hip belt squat training performed twice per week for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | Immediately after the intervention |
| Demand | 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. | Immediately after the intervention |
| Implementation | 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. | Immediately after the intervention |
| Practicality | Practicality will be assessed by evaluation of the adherence level, computed as the percentage of completed training sessions. | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain sensitivity | Pressure-pain threshold was assessed using a handheld pressure algometer. | Assessed at baseline and immediately after the intervention period |
| Muscle strength | Muscle strength was assessed in the hop belt squat exercise using a 5 repetition maximum test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Gistrup | 9260 | Denmark |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Assessed at baseline and immediately after the intervention period |
| Lumbar flexibility | Lumbar flexibility was assessed using a custom made test. | Assessed at baseline and immediately after the intervention period |
| Muscle activity | Electromyography was used to assess muscle activation. | Assessed at baseline and immediately after the intervention period |
| Oswetry Disability index | A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden). | Assessed at baseline and immediately after the intervention period |
| Health related quality of life | 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. | Assessed at baseline and immediately after the intervention period |
| Fear-avoidance Beliefs Questionnaire | Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief. | Assessed at baseline and immediately after the intervention period |
| Body composition | To assess changes in body composition a DEXA scan was performed. This test quantified lean body mass (kg) and fat mass (kg). | Assessed at baseline and immediately after the intervention period |
| D013568 |
| Pathological Conditions, Signs and Symptoms |