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Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

NCT ID: NCT05483608

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-11-12

Brief Summary

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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

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Conditions

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Chronic Low Back Pain

Keywords

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low back pain exercise vertical climbing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The physician screening participants and the primary outcome assessor will be blinded to group allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Vertical climbing ergometer exercise

Intervention Type OTHER

Exercise using the CLMBR, a vertical climbing exercise ergometer.

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.

Group Type ACTIVE_COMPARATOR

Recumbent cycling

Intervention Type OTHER

Exercise using a recumbent cycle ergometer

Interventions

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Vertical climbing ergometer exercise

Exercise using the CLMBR, a vertical climbing exercise ergometer.

Intervention Type OTHER

Recumbent cycling

Exercise using a recumbent cycle ergometer

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Jamie Mathew Wood

Program Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie Wood, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Union Square

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 21-1568

Identifier Type: -

Identifier Source: org_study_id