Spinal Cord Injury at T2 and BelowNCT03793595
O2 Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus UE Arm Bike Test in Adults With SCI
A study testing Seated Battle Ropes Protocol and Seated Upper Extremity Arm Bike in people with Spinal Cord Injury at T2 and Below, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in subjects with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury at T2 and Below
- What is being tested?
- Seated Battle Ropes Protocol and Seated Upper Extremity Arm Bike
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to Jan 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spinal cord lesion T2 or below
- Individuals with spinal cord injury for greater than six months
- Utilize manual wheelchair for greater than 10 hours a day
Who cannot join
- Current complaints of spinal, lower extremity or upper extremity pain or musculoskeletal disorder that prevents the subject from performing repetitive upper extremity cycling or grasping and swinging the weighted ropes against the floor
- A current diagnosis of a chronic or acute cardiovascular, metabolic, renal or pulmonary disease including use of a pacemaker
- Anyone currently taking beta blocker medication
- Anyone with blood pressure >140/90 at the time of testing or with in the 2 weeks prior to testing
- Diagnosed sickle cell disease or sickle cell trait
- Severe spasticity or joint contracture preventing subject from performing upper extremity cycling or swinging of weighted ropes
Show all 9Show fewer
- Subjects with current decubital ulcers
- History of autonomic dysreflexia in the last 6 months
- Require physician follow-up prior to starting exercise based on PAR-Q+ questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University
Houston, Texas, 77030
Wayne A Brewer, PhD, 713-794-2074, wbrewer@twu.edu
Wayne Brewer, PhD, MPH
About this study
Official title: Oxygen Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus Upper Extremity Arm Bike Test in Adults With Spinal Cord Injury
The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in subjects with spinal cord injury.
Read the detailed description
- Subjects will be scheduled for the first testing session after informed consent is obtained.
- Subjects will fill out PAR-Q+ to determine readiness for exercise testing
- Subjects will fill out additional Questionnaire to determine exclusion based on medical history
- Prior to the physical performance tests, each participant will be fitted with a mask that covers their face. This mask will be attached to a portable metabolic analyzer (Cosmed k5b). This device collects the air expired which allows for energy expenditure to be estimated.
- Each participant will be fitted with the proper sized mask that is connected to a small computer and power source supported at their upper back.
- A polar heart rate strap monitor will be worn around the chest. As the participant performs the physical performance tests, the Cosmed K5b measures the amount of carbon dioxide and oxygen from each breath to estimate the amount of energy expended during this task.
Session one:
- Prior to beginning the testing, testing procedure will be explained to participants
- Subjects blood pressure will be measured, and if a subject's average systolic or diastolic blood pressure exceeds 140 or 90 mmHg, respectively, the subject will be asked to return another day to perform the study procedures. If the blood pressure remains elevated on either one of these measures, the subject will be excused from this study.
- Subjects will then perform either the upper extremity cycling protocol or battle ropes protocol first. The other will be performed on the subsequent testing date
- If the subject is performing the upper extremity arm cycle test: Each subject will perform a modified version of the ramped YMCA cycle test using a Upper Extremity Cycle Ergometer and a portable metabolic cart
- The ramped version of the YMCA cycle test will begin with the subject cycling at a workload of 25 watts at a rate of 60 revolutions per minute (rpm) using a metronome set at 120 beats per minute.
- Each subject will pedal for 3-minute warm-up period at the 10 watts with the 60 rpm rate. After the 3-minute warm-up, the workload will increase by 10 watts each minute starting at 25 watts at pedal rate of 60 rpm until the subjects meets the termination criteria as described below.
- The portable metabolic cart is an instrument that measures levels of expired gases from the subject as he or she exercises that will be analyzed and displayed on a computer monitor. The subject will wear a face mask during the test. A Polar® heart rate monitor will be worn on the chest, directly on the skin of each subject to obtain heart rate measurements.
- The goal is for the participant to perform the ramped exercise test using the protocol described above and below until one or more of the following occurs, at which time the test will be terminated: the participant requests the test to be stopped, a respiratory exchange ratio of >1.0 is achieved, or one of the following physiologic and/or subjective signs/symptoms are present:
- i. A drop in systolic blood pressure >10 mmHg with the increasing work load
- ii.An increase in systolic and/or diastolic blood pressure >250 mmHg or 115 mmHg, respectively.
- iii.Reported chest or arm pain (angina)
- iv.Severe shortness of breath, cyanosis, pallor, lightheadedness, dizziness or confusion
- v.No increase in heart rate despite increase in work load
- vi.Complaints of severe fatigue
- vii.The subject is unable to maintain a pedal rate of 50 rpm
- viii.Borg 6-20 Perceived exertion scale score >=20
- The subjects heart rate will be recorded at the last 15-30 seconds of each minute during the test.
- Each subject's blood pressure will be taken before the test commences, every three minutes during the test and once the test procedure is terminated.
- The Borg 6-20 perceived exertion scale will be used to monitor the participant's rating of perceived exertion every three minutes during the test. If at any time during the test, the subject rates his or her perceived level of exertion at a level of 20, the test will be terminated.
- Session two: will occur at least three days after session one.
- If the subject is performing the sitting battling rope:
- a. A 10 to 15-minute demonstration will be provided to each subject on the proper use of the battling ropes using the double arm swing technique
- b. A 30 foot,1.5-inch diameter rope that will be anchored to a large weight
- Each subject will position him/herself in their manual wheelchair with feet flat on the floor or foot rests at shoulder width apart.
- d. The subject's manual wheelchair will be secured using dumbbells and weights as pictured below
- e. A 3-minute warm up period will be given to each subject prior to the exercise protocol
- The subject will be fitted with a face mask attached to the metabolic cart as described previously.
- On command, each subject will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.
- At each rest break, the subject will be asked to rate his/her levels of exertion using the Borg 6-20 as described previously.
- i. If a subject cannot complete the double arm rope swing at the required cadence or if the rope does not undulate through the entire length of the rope towards the anchor point, or if the subject requests to stop, the protocol will be terminated.
- Reusable Mask cleaning procedure, performed following each participant
- a. the following parts must be 1) rinsed with warm soapy water, 2) soaked in CITADEX solution 15 minutes, 3) rinsed with cool running water again, 4) laid out to dry:
- b. Turbine (fan tube)
- c. Flowmeter seal (black plastic cone ring)
- d. Flowmeter cap (tan circle with black and silver emblem on it)
- e. Face mask (blue plastic inserted vertically to avoid air pockets on interior)
- After each use, the following parts must be wiped down with baby wipes and at the end of the day must be soaked in soapy water for 10 minutes then wrung out and laid out to dry:
- a. Head strap
- b. Polar monitor strap
- c. After each use, the following must be wiped with a disinfectant wipe:
- d. Polar hear monitor
- Conditions
- Spinal Cord Injury at T2 and Below
- Being tested
- Seated Battle Ropes Protocol, Seated Upper Extremity Arm Bike
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated Battle Ropes ProtocolDevice
Participants will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.
Seated Upper Extremity Arm BikeDevice
A modified Young Men's Christian Association (YMCA) cycle test will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Seated Battle Ropes Protocol | Experimental | Not described Receives: Device: Seated Battle Ropes Protocol |
| Seated Upper Extremity Arm Bike | Active comparator | Not described Receives: Device: Seated Upper Extremity Arm Bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)
VO2max will be measured using a portable metabolic cart (Cosmed k5b).
Measured: about 10-15 minutes after start of the protocol
Secondary outcomes (3)
Heart Rate
Measured: about 10-15 minutes after start of the protocol
Rate of perceived exertion as assessed by the Borg 6-20 Perceived exertion scale
The Borg 6-20 Perceived exertion scale score ranges from 6-20, higher score indicates a worse outcome.
Measured: about 10-15 minutes after start of the protocol
Blood pressure
Measured: about 10-15 minutes after start of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start20 Mar 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury at T2 and BelowStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Brewer, Texas Woman's University
- Investigators
- Wayne A Brewer, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793595
- Sponsor's protocol ID
- IRB-FY2019-34
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus Upper Extremity Arm Bike Test in Adults With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03793595
- Acronym / sponsor ID
- IRB-FY2019-34
- Conditions
- Spinal Cord Injury at T2 and Below
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Jan 2019 (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.
The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in subjects with spinal cord injury.
Detailed description
- Subjects will be scheduled for the first testing session after informed consent is obtained.
- Subjects will fill out PAR-Q+ to determine readiness for exercise testing
- Subjects will fill out additional Questionnaire to determine exclusion based on medical history
- Prior to the physical performance tests, each participant will be fitted with a mask that covers their face. This mask will be attached to a portable metabolic analyzer (Cosmed k5b). This device collects the air expired which allows for energy expenditure to be estimated.
- Each participant will be fitted with the proper sized mask that is connected to a small computer and power source supported at their upper back.
- A polar heart rate strap monitor will be worn around the chest. As the participant performs the physical performance tests, the Cosmed K5b measures the amount of carbon dioxide and oxygen from each breath to estimate the amount of energy expended during this task.
Session one:
- Prior to beginning the testing, testing procedure will be explained to participants
- Subjects blood pressure will be measured, and if a subject's average systolic or diastolic blood pressure exceeds 140 or 90 mmHg, respectively, the subject will be asked to return another day to perform the study procedures. If the blood pressure remains elevated on either one of these measures, the subject will be excused from this study.
- Subjects will then perform either the upper extremity cycling protocol or battle ropes protocol first. The other will be performed on the subsequent testing date
- If the subject is performing the upper extremity arm cycle test: Each subject will perform a modified version of the ramped YMCA cycle test using a Upper Extremity Cycle Ergometer and a portable metabolic cart
- The ramped version of the YMCA cycle test will begin with the subject cycling at a workload of 25 watts at a rate of 60 revolutions per minute (rpm) using a metronome set at 120 beats per minute.
- Each subject will pedal for 3-minute warm-up period at the 10 watts with the 60 rpm rate. After the 3-minute warm-up, the workload will increase by 10 watts each minute starting at 25 watts at pedal rate of 60 rpm until the subjects meets the termination criteria as described below.
- The portable metabolic cart is an instrument that measures levels of expired gases from the subject as he or she exercises that will be analyzed and displayed on a computer monitor. The subject will wear a face mask during the test. A Polar® heart rate monitor will be worn on the chest, directly on the skin of each subject to obtain heart rate measurements.
- The goal is for the participant to perform the ramped exercise test using the protocol described above and below until one or more of the following occurs, at which time the test will be terminated: the participant requests the test to be stopped, a respiratory exchange ratio of >1.0 is achieved, or one of the following physiologic and/or subjective signs/symptoms are present:
- i. A drop in systolic blood pressure >10 mmHg with the increasing work load
- ii.An increase in systolic and/or diastolic blood pressure >250 mmHg or 115 mmHg, respectively.
- iii.Reported chest or arm pain (angina)
- iv.Severe shortness of breath, cyanosis, pallor, lightheadedness, dizziness or confusion
- v.No increase in heart rate despite increase in work load
- vi.Complaints of severe fatigue
- vii.The subject is unable to maintain a pedal rate of 50 rpm
- viii.Borg 6-20 Perceived exertion scale score >=20
- The subjects heart rate will be recorded at the last 15-30 seconds of each minute during the test.
- Each subject's blood pressure will be taken before the test commences, every three minutes during the test and once the test procedure is terminated.
- The Borg 6-20 perceived exertion scale will be used to monitor the participant's rating of perceived exertion every three minutes during the test. If at any time during the test, the subject rates his or her perceived level of exertion at a level of 20, the test will be terminated.
- Session two: will occur at least three days after session one.
- If the subject is performing the sitting battling rope:
- a. A 10 to 15-minute demonstration will be provided to each subject on the proper use of the battling ropes using the double arm swing technique
- b. A 30 foot,1.5-inch diameter rope that will be anchored to a large weight
- Each subject will position him/herself in their manual wheelchair with feet flat on the floor or foot rests at shoulder width apart.
- d. The subject's manual wheelchair will be secured using dumbbells and weights as pictured below
- e. A 3-minute warm up period will be given to each subject prior to the exercise protocol
- The subject will be fitted with a face mask attached to the metabolic cart as described previously.
- On command, each subject will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.
- At each rest break, the subject will be asked to rate his/her levels of exertion using the Borg 6-20 as described previously.
- i. If a subject cannot complete the double arm rope swing at the required cadence or if the rope does not undulate through the entire length of the rope towards the anchor point, or if the subject requests to stop, the protocol will be terminated.
- Reusable Mask cleaning procedure, performed following each participant
- a. the following parts must be 1) rinsed with warm soapy water, 2) soaked in CITADEX solution 15 minutes, 3) rinsed with cool running water again, 4) laid out to dry:
- b. Turbine (fan tube)
- c. Flowmeter seal (black plastic cone ring)
- d. Flowmeter cap (tan circle with black and silver emblem on it)
- e. Face mask (blue plastic inserted vertically to avoid air pockets on interior)
- After each use, the following parts must be wiped down with baby wipes and at the end of the day must be soaked in soapy water for 10 minutes then wrung out and laid out to dry:
- a. Head strap
- b. Polar monitor strap
- c. After each use, the following must be wiped with a disinfectant wipe:
- d. Polar hear monitor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seated Battle Ropes Protocol | Experimental | Device: Seated Battle Ropes Protocol |
| Seated Upper Extremity Arm Bike | Active comparator | Device: Seated Upper Extremity Arm Bike |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal cord lesion T2 or below
- Individuals with spinal cord injury for greater than six months
- Utilize manual wheelchair for greater than 10 hours a day
Key exclusion criteria (9 listed)
- Current complaints of spinal, lower extremity or upper extremity pain or musculoskeletal disorder that prevents the subject from performing repetitive upper extremity cycling or grasping and swinging the weighted ropes against the floor
- A current diagnosis of a chronic or acute cardiovascular, metabolic, renal or pulmonary disease including use of a pacemaker
- Anyone currently taking beta blocker medication
- Anyone with blood pressure >140/90 at the time of testing or with in the 2 weeks prior to testing
- Diagnosed sickle cell disease or sickle cell trait
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 |
|---|---|---|
| Seated Battle Ropes ProtocolParticipants will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times. | Device | Seated Battle Ropes Protocol |
| Seated Upper Extremity Arm BikeA modified Young Men's Christian Association (YMCA) cycle test will be performed. | Device | Seated Upper Extremity Arm Bike |
Primary outcome
Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)
Time frame: about 10-15 minutes after start of the protocol
VO2max will be measured using a portable metabolic cart (Cosmed k5b).
3 secondary outcomes
Heart Rate
Time frame: about 10-15 minutes after start of the protocol
Rate of perceived exertion as assessed by the Borg 6-20 Perceived exertion scale
Time frame: about 10-15 minutes after start of the protocol
Blood pressure
Time frame: about 10-15 minutes after start of the protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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.
Wayne A Brewer, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated Battle Ropes Protocol and Seated Upper Extremity Arm Bike in people with Spinal Cord Injury at T2 and Below, run by Texas Woman's University 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wayne A Brewer, PhD (713-794-2074, wbrewer@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max) (time frame: about 10-15 minutes after start of the protocol). 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 19 Apr 2021.