Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03793595 |
| Other study ID # |
IRB-FY2019-34 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2019 |
| Est. completion date |
January 2022 |
Study information
| Verified date |
April 2021 |
| Source |
Texas Woman's University |
| Contact |
Wayne A Brewer, PhD |
| Phone |
713-794-2074 |
| Email |
wbrewer[@]twu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
Description:
1. Subjects will be scheduled for the first testing session after informed consent is
obtained.
2. Subjects will fill out PAR-Q+ to determine readiness for exercise testing
3. Subjects will fill out additional Questionnaire to determine exclusion based on medical
history
4. 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.
5. 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.
6. 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:
1. Prior to beginning the testing, testing procedure will be explained to participants
2. 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.
3. 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
4. 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.
5. 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.
6. 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
7. The subjects heart rate will be recorded at the last 15-30 seconds of each minute during
the test.
8. 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.
9. 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.
10. Session two: will occur at least three days after session one.
11. 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
c. 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
f. The subject will be fitted with a face mask attached to the metabolic cart as
described previously.
g. 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.
h. 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.
12. 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)
13. 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
