Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Study Overview
=================
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.

Official Title
-----------------
Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Other: Vertical climbing ergometer exercise
* Other: Recumbent cycling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Confirmed chronic (>12 weeks) low back pain at screening assessment (based on patient history) Ability to comply with the current Mount Sinai Health system COVID-19 requirements for research participants (e.g., vaccination, masks) Exclusion criteria: Criteria will be evaluated during the clinical evaluation at the screening visit. All determinations will be the decision of the study physician: Less than 2/10 low back pain on 0-10 numeric rating scale for average pain over past 7 days at baseline assessment Any cardiovascular or musculoskeletal contraindication to exercise Impaired balance contraindicating exercise Known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments Current pregnancy Current medications or new medications commenced that may impact the ability for change to be detected in study Any other contraindication in the opinion of the study physician

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertical climbing ergometer exercise<br>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<br>* Exercise using the CLMBR, a vertical climbing exercise ergometer.<br>|
| Active Comparator: Recumbent cycling<br>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<br>* Exercise using a recumbent cycle ergometer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, exercise, vertical climbing