Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Mount Sinai Health System

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Recumbent cycling; Other: Vertical climbing ergometer exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05483608

GCO 21-1568

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

Vertical climbing ergometer exercise

Experimental group

Description:

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.

Treatment:

Other: Vertical climbing ergometer exercise

Recumbent cycling

Active Comparator group

Description:

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.

Treatment:

Other: Recumbent cycling