An interventional study of performing exercises in a weight bearing posture and performing exercises in a non weight bearing posture in Osteoporosis and Low Back Pain, sponsored by Bait Balev Hospital. Completed at 1 site in Israel. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by Bait Balev Hospital · Not applicable, Interventional, and Treatment
The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain.
40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer.
Statistical analysis will be made in order to compare the dependent variables between groups.
40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in Bat-Yam, Israel. Each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS and lumbar range of motion measurement by a digital Inclinometer. By order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. After recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. After each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. A third identical test will be preformed two months after finishing the program.
After all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 53 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Bait Balev Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
performing exercises in a weight bearing posture
Other: performing exercises in a weight bearing posture
performing exercises in a non- weight bearing posture
Other: performing exercises in a non weight bearing posture
20 participants will perform exercises in a weight bearing posture
20 participants will perform exercises in a non weight bearing posture
Change of physical disability
the Roland Morris Disability Questionnaire. The score of the questionnaire is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.
Time frame: 3 months
change in lumbar range of motion - flexion and extension
digital inclinometer. The change will be assessed by the difference in number of degrees measured
Time frame: 3 months
change in pain intensity
Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)
Time frame: 3 months
change in health related quality of life
the Short Form-36 (SF-36) quality of life Questionnaire. A questionnaire of 36 questions, each response receives a specific value
Time frame: 3 months
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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