Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

NCT05483608 | Completed DMC

• 1 other identifier: GCO 21-1568
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain; exercise; vertical climbing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Numeric Pain Rating Scale

  8 weeks

• Minutes of exercise completed

  8 weeks

• Change in The Oswestry Disability Index

  Baseline and 8 weeks

Study Arms (2)

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.

Other: Vertical climbing ergometer exercise

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.

Other: Recumbent cycling

Interventions

Vertical climbing ergometer exercise OTHER

Exercise using the CLMBR, a vertical climbing exercise ergometer.

Vertical climbing ergometer exercise

Recumbent cycling OTHER

Exercise using a recumbent cycle ergometer

Recumbent cycling

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Union Square

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jamie Wood, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physician screening participants and the primary outcome assessor will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Manager

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: November 8, 2022
• Primary Completion: November 12, 2023
• Study Completion: November 12, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)