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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertical climbing ergometer exercise | Experimental | 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. |
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| Recumbent cycling | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertical climbing ergometer exercise | Other | Exercise using the CLMBR, a vertical climbing exercise ergometer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events | 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. | 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. | Baseline and 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Wood, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Union Square | New York | New York | 10003 | United States |
Data will only be shared upon reasonable request
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The physician screening participants and the primary outcome assessor will be blinded to group allocation
| Recumbent cycling | Other | Exercise using a recumbent cycle ergometer |
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| Minutes of exercise completed |
Minutes of exercise completed during the exercise sessions. |
| 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. | Baseline and 8 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |