Back to resultsVertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vertical climbing ergometer exercise
Recumbent cycling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, exercise, vertical climbing
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
Sites / Locations
- Mount Sinai Union SquareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vertical climbing ergometer exercise
Recumbent cycling
Arm 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.
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.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Incidence of adverse events
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.
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.
Secondary Outcome Measures
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).
Minutes of exercise completed
Minutes of exercise completed during the exercise sessions.
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.
Full Information
NCT ID
NCT05483608
First Posted
July 31, 2022
Last Updated
January 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05483608
Brief Title
Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
Official Title
Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, exercise, vertical climbing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The physician screening participants and the primary outcome assessor will be blinded to group allocation
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vertical climbing ergometer exercise
Arm Type
Experimental
Arm 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.
Arm Title
Recumbent cycling
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Vertical climbing ergometer exercise
Intervention Description
Exercise using the CLMBR, a vertical climbing exercise ergometer.
Intervention Type
Other
Intervention Name(s)
Recumbent cycling
Intervention Description
Exercise using a recumbent cycle ergometer
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Incidence of adverse events
Time Frame
8 Weeks
Title
Number of completed exercise sessions
Description
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.
Time Frame
8 Weeks
Title
Change in Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline and 8 Weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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).
Time Frame
8 weeks
Title
Minutes of exercise completed
Description
Minutes of exercise completed during the exercise sessions.
Time Frame
8 weeks
Title
Change in The Oswestry Disability Index
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Wood, PhD
Phone
212-241-8454
Email
jamie.wood@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Wood, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Union Square
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will only be shared upon reasonable request
Learn more about this trial
Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
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