Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04926350 |
| Other study ID # |
12183 / 2018-018-A1-R1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2018 |
| Est. completion date |
April 29, 2019 |
Study information
| Verified date |
June 2021 |
| Source |
Texas A&M University Kingsville |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this investigation is to determine the impact of simple resistance exercise
breaks on physical activity and prolonged sedentary behavior as well as on ratings of
discomfort, fatigue, and sleepiness. Participants will be enrolled in a cross-over designed
study, where they will be assessed for normal activity patterns and ratings of discomfort,
fatigue, and sleepiness during a typical week and compared to a week where they engage in
hourly resistance exercise breaks. Subjects will also complete a feasibility questionnaire at
the end to determine if such programming could be implemented into daily living. The
hypothesis is that engaging in these simple, hourly resistance breaks will result in
decreased ratings of discomfort, fatigue, and sleepiness as well as ratings of high
feasibility for implementation of similar resistance exercise programming into their normal,
everyday life. Total time spent enrolled in the study will be 4 weeks, however, the
participants will only need to report to the lab on 5 different occasions totaling 120
minutes split over those 5 days. Visit one will be roughly 60 minutes long, with the
following 4 visits taking roughly 15 minutes each with a visit at the beginning of the week
and end of the week for both the control and experimental week.
Description:
Each participant will encounter 1 familiarization session and 4 other brief sessions
throughout the study. The study will consist of a 4 week protocol, with the first week having
one familiarization visit, the second week being a baseline assessment week of normal
activity, the third week being a washout period where no assessment is being done, and the
fourth week being another assessment week while also completing the hourly resistance
exercise breaks. Total time required for participants to report to the laboratory will be 120
minutes, but will be split over 5 visits (visit one: 60 minutes, visit two: 15 minutes, visit
three: 15 minutes, visit four: 15 minutes, visit 5: 15 minutes).
The familiarization day will consist of the subject going through an initial screening to
determine eligibility to participate in the study, as well as signing the informed consent.
Following this, the participants will complete questionnaires to assess characteristics of
interest (age, ethnicity, and activity level) and any other relevant characteristics deemed
to be important to describe the population. Individuals will then be shown the journals and
how to use them (journal attached). These journals will be used to track their ratings of
discomfort, fatigue, and sleepiness across each of the days for both assessment weeks. Next,
the individual will be shown each of the exercises that will be used during the resistance
exercise break week and will be asked by the PI to complete each one so that the PI can
provide any feedback to correct the movements to ensure safety. The subjects will also be
given typed handouts describing each exercise in detail for their own records. Lastly, the
subjects will be shown the activity monitors and how they will be applied to their body and
how to replace the adhesive tape if needed during the weeks they are wearing the device (See
attachment). This visit is expected to last roughly 60 minutes.
Visit #2 (week 2) will take place Monday morning at 8:00 am the week following the
familiarization visit and will last roughly 15 minutes. At this visit, the PI will secure the
activity monitor to the subject, and provide extra adhesive strips if needed. The subject
will also receive their journal for the week to assess discomfort, fatigue, and sleepiness.
The subject will be asked to track their ratings at three separate time points (morning:
between 8:00-9:00 am, mid-day: between 1:00-2:00 pm, and evening: between 6:00-7:00 pm)
across each of the next 7 days (Monday-Sunday). During the 7 days, the subject will be
wearing the activity monitor the entire time (awake and sleep) and will only be removed if
swimming/bathing (shower is ok: waterproof). The subject will be asked to go about their week
as they normally do, with no extra intervention, to track activity and ratings for a typical
week. This week will not have them completing any exercises and will serve as a control week
for assessing physical activity pattern. Total time spent filling out the journal will be
roughly 2-3 minutes per time, so roughly 9 minutes per day, and 63 minutes for the entire
week.
Visit #3 (week 3) will take place on the Monday following the 7 days of assessment. The PI
will remove the activity monitor and collect any extra adhesive strips. The subject will also
turn in their journal that was used to track their ratings for the previous week. This visit
will take roughly 15 minutes. At this point the subject will be allowed to leave and begin
the washout week with no assessment.
Visit #4 (Week 4) will take place Monday morning at 8:00 am the week following the washout
week and will last roughly 15 minutes. At this visit, the PI will secure the activity monitor
to the subject, and provide extra adhesive strips if needed. The subject will also receive
their journal for the week to assess discomfort, fatigue, and sleepiness. The subject will be
asked to track their ratings at three separate time points (morning: between 8:00-9:00 am,
mid-day: between 1:00-2:00 pm, and evening: between 6:00-7:00 pm) across each of the next 7
days (Monday-Sunday). During the 7 days, the subject will be wearing the activity monitor the
entire time (awake and sleep) and will only be removed if swimming/bathing (shower is ok:
waterproof). The subject will also now be asked to completely hourly resistance exercise
breaks each hour for a total of eight exercises per day. Subjects will be asked to complete 2
sets of 15 repetitions each for all eight exercises with a minute rest in between sets. Each
break should take less than 5 minutes. All exercises will be low intensity that utilize their
own body weight as resistance or use a light resistance band with handles. Exercises will be
split in groups of 4 with one group in the morning and one in the afternoon, with one
exercise taking place per time slot. Time slots will be as follows: between 9:00-10:00 am,
10-11:00 am, 11:00-12:00 pm, and 12:00-1:00 pm, as well as from 2:00-3:00 pm, 3:00-4:00 pm,
4:00-5:00pm, and 5:00-6:00pm. Each exercise in detail is described in the handout that will
be given to each participant (attached). This will require the participant to be engaged in
exercise roughly 24 minutes per day, for a total of 168 minutes of exercise for the week. The
participant will also be filling out the journals for the second assessment week similar to
the first assessment week, totaling roughly 63 minutes for the week completing the journals.
Visit #5 (week 4) will take place on the Monday following the second week of 7 day
assessments. The PI will remove the activity monitor and collect any extra adhesive strips.
The subject will also turn in their journal that was used to track their ratings for the
previous week. Finally the subjects will be asked to complete a brief questionnaire about the
feasibility of such programming in their daily life. This visit will take roughly 15 minutes.
This will complete the subject's participation in the study.
Information about participants and related to this study will be kept confidential to the
extent permitted or required by law. Hard copies of the data collection materials will kept
under lock and key for a period of no less than five years, then disposed of as sensitive
materials according to University policy/procedures. Data collections sheets and informed
consent documents will be stored separately. All data collection forms will not have any
identifiable information on them and will have an ID number to link the information to the
participant. Form linking participant name to ID will be kept electronically in a password
protected computer file along with the reduced and analyzed data that is collected.
