An interventional study of Vertical climbing ergometer exercise and Recumbent cycling in Chronic Low Back Pain, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
This is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a recumbent cycling ergometer. This feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion criteria:
8 weeks of 3 times per week (24 sessions in total) of 30 minutes of vertical climbing ergometer exercise using the CLMBR. Intensity will be prescribed at a level of 12 to 14 on the Borg Rate of Perceived Exertion Scale.
Other: Vertical climbing ergometer exercise
8 weeks of 3 times per week (24 sessions in total) of 30 minutes of recumbent cycle ergometer exercise. Intensity will be prescribed at a level of 12 to 14 on the Borg Rate of Perceived Exertion Scale.
Other: Recumbent cycling
Exercise using the CLMBR, a vertical climbing exercise ergometer.
Exercise using a recumbent cycle ergometer
Incidence of adverse events
Incidence of adverse events
Time frame: 8 Weeks
Number of completed exercise sessions
The number of completed exercise sessions. A completed session is defined as achieving a minimum of 15 minutes of active exercise during a commenced session.
Time frame: 8 Weeks
Change in Numeric Pain Rating Scale
11-point numerical rating scale evaluating average pain intensity over the past 7 days. A clinically meaningful difference will be considered as 2 points. Change in Numeric Pain Rating scale at 8 weeks as compared to baseline. Full scale from 0-10, with higher score indicating more pain.
Time frame: Baseline and 8 Weeks
Numeric Pain Rating Scale
Average acute change in pain intensity on 11-point numerical rating scale (higher = worse pain) during or immediately post-exercise, or reported at the beginning of the following session (unless believed that the change in pain was caused by something unrelated to the study intervention).
Time frame: 8 weeks
Minutes of exercise completed
Minutes of exercise completed during the exercise sessions.
Time frame: 8 weeks
Change in The Oswestry Disability Index
The Oswestry Disability Index will be used to evaluate changes in disability in day-to-day activities as a result of low back pain. A clinically meaningful difference will be considered as 10 points. Full scale is 0 (no disability) to 50 (complete disability), higher score indicating poorer health outcomes.
Time frame: Baseline and 8 weeks
Plan to share: No — Data will only be shared upon reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai