Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: Vertical climbing ergometer exercise; Other: Recumbent cycling

• Registration Number: NCT05483608
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-02
• Study Start: 2022-11-08
• Primary Completion: 2023-11-12
• Study Completion: 2023-11-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertical climbing ergometer exercise	Vertical climbing ergometer exercise	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.
Recumbent cycling	Recumbent cycling	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.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Pain Rating Scale	Baseline and 8 Weeks	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.
Incidence of adverse events	8 Weeks	Incidence of adverse events
Number of completed exercise sessions	8 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	8 weeks	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).
Minutes of exercise completed	8 weeks	Minutes of exercise completed during the exercise sessions.
Change in The Oswestry Disability Index	Baseline and 8 weeks	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.

Trial Locations

Locations (1)

Mount Sinai Union Square; 🇺🇸 New York, New York, United States