Chronic Low Back PainNCT05483608
Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
A study testing Vertical climbing ergometer exercise and Recumbent cycling in people with Chronic Low Back Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Vertical climbing ergometer exercise and Recumbent cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 12 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain
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
- Being tested
- Vertical climbing ergometer exercise, Recumbent cycling
- Keywords
- low back pain, exercise, vertical climbing
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical climbing ergometer exerciseOther
Exercise using the CLMBR, a vertical climbing exercise ergometer.
Recumbent cyclingOther
Exercise using a recumbent cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Recumbent cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Incidence of adverse events
Measured: 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.
Measured: 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.
Measured: Baseline and 8 Weeks
Secondary outcomes (3)
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).
Measured: 8 weeks
Minutes of exercise completed
Minutes of exercise completed during the exercise sessions.
Measured: 8 weeks
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start8 Nov 2022
- Primary completion12 Nov 2023
- Study completion12 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Mathew Wood, Icahn School of Medicine at Mount Sinai
- Investigators
- Jamie Wood, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483608
- Sponsor's protocol ID
- GCO 21-1568
- Status last verified
- Dec 2023
- First submitted
- 31 Jul 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05483608
- Acronym / sponsor ID
- GCO 21-1568
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, exercise, vertical climbing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertical climbing ergometer exercise | Experimental | Other: Vertical climbing ergometer exercise8 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. |
| Recumbent cycling | Active comparator | Other: Recumbent cycling8 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertical climbing ergometer exerciseExercise using the CLMBR, a vertical climbing exercise ergometer. | Other | Vertical climbing ergometer exercise |
| Recumbent cyclingExercise using a recumbent cycle ergometer | Other | Recumbent cycling |
Primary outcome
Incidence of adverse events
Time frame: 8 Weeks
Incidence of adverse events
Number of completed exercise sessions
Time frame: 8 Weeks
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
Time frame: Baseline and 8 Weeks
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.
3 secondary outcomes
Numeric Pain Rating Scale
Time frame: 8 weeks
Minutes of exercise completed
Time frame: 8 weeks
Change in The Oswestry Disability Index
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No. Data will only be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Wood, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical climbing ergometer exercise and Recumbent cycling in people with Chronic Low Back Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.