Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Last updated: December 8, 2023
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Treatment

Recumbent cycling

Vertical climbing ergometer exercise

Clinical Study ID

NCT05483608
GCO 21-1568
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for theduration of the study
  • Confirmed chronic (>12 weeks) low back pain at screening assessment (based on patienthistory)
  • Ability to comply with the current Mount Sinai Health system COVID-19 requirements forresearch participants (e.g., vaccination, masks)

Exclusion

Exclusion criteria:

  • Criteria will be evaluated during the clinical evaluation at the screening visit. Alldeterminations 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 7days at baseline assessment
  • Any cardiovascular or musculoskeletal contraindication to exercise
  • Impaired balance contraindicating exercise
  • Known psychological illnesses or cognitive impairments contraindicating exercise orpreventing the ability to complete study assessments
  • Current pregnancy
  • Current medications or new medications commenced that may impact the ability forchange to be detected in study
  • Any other contraindication in the opinion of the study physician

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Recumbent cycling
Phase:
Study Start date:
November 08, 2022
Estimated Completion Date:
November 12, 2023

Connect with a study center

  • Mount Sinai Union Square

    New York, New York 10003
    United States

    Site Not Available

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