Sedentary BehaviorREXNCT04926350
Resistance Exercise Breaks Improve Ratings of Discomfort and Fatigue in College Students (REX)
A study testing Resistance Exercise in people with Sedentary Behavior and Fatigue, run by Texas A&M University Kingsville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Fatigue, Sleepiness
- What is being tested?
- Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 29 Apr 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible, participants need to be actively taking college classes, between the ages of 18 and 35 years old, and have no contraindications to participating in physical activity.
Who cannot join
- Any contraindication for physical activity participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University-Kingsville Human Performance Laboratory
Kingsville, Texas, 78363
About this study
Official title: Resistance Exercise Breaks Improve Ratings of Discomfort and Fatigue in College
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.
Read the detailed 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.
- Conditions
- Sedentary Behavior, Fatigue, Sleepiness, Pain
- Being tested
- Resistance Exercise
- Keywords
- physical activity, resistance exercise
- Medical subject headings
- Sedentary Behavior, Fatigue, Sleepiness, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
8 total resistance exercises that target all major muscle groups
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Tracking of outcomes during a normal week |
| Resistance Exercise | Experimental | Tracking of outcomes during a normal week with the addition of daily resistance exercise breaks (8 breaks per day) Receives: Behavioral: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
number of daily steps taken
Measured: a week
Sedentary behavior
amount of daily sedentary behavior accumulated
Measured: a week
Secondary outcomes (4)
Physical discomfort
Subjective ratings of discomfort for 15 separate sites on the body using 100 pt visual analog scale
Measured: assessed morning, mid-day, and evening over a week period
Physical Fatigue
Subjective rating of physical fatigue using a single 100 pt visual analog scale
Measured: assessed morning, mid-day, and evening over a week period
Mental Fatigue
Subjective rating of mental fatigue using a single 100 pt visual analog scale
Measured: assessed morning, mid-day, and evening over a week period
Sleepiness
Single value reported from Karolinska sleeping scale ranging from 1 to 9
Measured: assessed morning, mid-day, and evening over a week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start9 Apr 2018
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University Kingsville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert J. Kowalsky, Texas A&M University Kingsville
- Investigators
- Robert J Kowalsky, Ph.D., Principal investigator, Texas A&M University Kingsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926350
- Sponsor's protocol ID
- 12183 / 2018-018-A1-R1
- Acronym
- REX
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise Breaks Improve Ratings of Discomfort and Fatigue in College
- ClinicalTrials.gov ID
- NCT04926350
- Acronym / sponsor ID
- REX / 12183 / 2018-018-A1-R1
- Conditions
- Sedentary Behavior, Fatigue, Sleepiness, Pain
- Keywords
- physical activity, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas A&M University KingsvilleUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 15 Jun 2021 (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 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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Tracking of outcomes during a normal week |
| Resistance Exercise | Experimental | Behavioral: Resistance ExerciseTracking of outcomes during a normal week with the addition of daily resistance exercise breaks (8 breaks per day) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be eligible, participants need to be actively taking college classes, between the ages of 18 and 35 years old, and have no contraindications to participating in physical activity.
Key exclusion criteria (1 listed)
- Any contraindication for physical activity participation
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 |
|---|---|---|
| Resistance Exercise8 total resistance exercises that target all major muscle groups | Behavioural | Resistance Exercise |
Primary outcome
Physical activity
Time frame: a week
number of daily steps taken
Sedentary behavior
Time frame: a week
amount of daily sedentary behavior accumulated
4 secondary outcomes
Physical discomfort
Time frame: assessed morning, mid-day, and evening over a week period
Physical Fatigue
Time frame: assessed morning, mid-day, and evening over a week period
Mental Fatigue
Time frame: assessed morning, mid-day, and evening over a week period
Sleepiness
Time frame: assessed morning, mid-day, and evening over a week period
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 15 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Robert J Kowalsky, Ph.D. principal investigator
Texas A&M University Kingsville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Sedentary Behavior and Fatigue, run by Texas A&M University Kingsville 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 1 inclusion and 1 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 15 Jun 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?
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?
Physical activity (time frame: a week). The study lists 2 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 15 Jun 2021.