- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05615831
The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences
The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences on Physical Performance, Muscle Hypertrophy, and Blood Biomarkers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Previous studies indicated a reduced workload (i.e., lifting lighter weight) combined with blood flow restriction leads to increased fat-free mass and muscle strength. However, females have been underrepresented in the blood flow restriction literature. Therefore, no study has investigated whether males and females of different age groups have different adaptations in fat-free mass, muscle strength, and performance outcomes following resistance training using blood flow restriction.
The primary objective will be to investigate sex differences in fat-free mass following six weeks of resistance training combined with blood flow restriction in young and older adults.
The secondary objective is to investigate sex differences in muscle strength, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.
Briefly, participants between 19-30 years and 65 years and older will be recruited to participate in this study. Participants will present to the laboratory for two baseline testing visits interspersed with a minimum of four days. The first testing visit will include a variety of questionnaires, a blood draw, lipid and glucose, a dual-energy x-ray absorptiometry scan, anthropometrics, and a submaximal VO2. The second visit will include several physical function tests, such as the short physical performance battery and the Y-balance test, as well as a high-intensity isokinetic fatigue test using isokinetic dynamometry and 1-repetition maximum testing.
Upon completion of baseline testing, participants are enrolled in the exercise program. The first exercise session includes a blood draw before and immediately after the training session. This procedure will be duplicated at the final exercise session at the end of the six weeks.
Participants' full occlusion will be estimated using the formula developed by Loenneke et al. (2015). Then each participant's occlusion will be set at 60% of each individual's total limb occlusion. This will be used in combination with the following exercises incline chest press, seated row, leg press, knee extension, and knee flexion performed at 30% of 1RM. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
Following the completion of the six weeks of exercise, participants will again present to the laboratory for two follow-up visits similar to the first two baseline visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
-
Fredericton, New Brunswick, Canada, E3B 5A3
- University of New Brunswick - Kinesiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 19 and 100 years
- Sedentary (not meeting physical activity guidelines), but otherwise healthy
Exclusion Criteria:
- Aged outside the threshold
- Uncontrolled hypertension
- Presence of cardiovascular disease
- Either surgery, bone fracture, or skin graft within the previous three months
- Uncontrolled diabetes mellitus
- Pregnancy
- Individuals taking medications known to increase risk of blood clotting
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Young adult (19-30 years)
Individuals aged 19-30 who are not physically active will participate in resistance training combined with blood flow restriction.
|
Participants will perform six weeks of blood flow restriction (60% occlusion) combined with resistance training at 30% of 1RM.
The intervention comprises five exercises: incline chest press, seated row, leg press, knee extension, and knee flexion.
The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise.
There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
|
|
Experimental: Older adults adult (aged 65 years and older)
Individuals aged 65 years and older who are not physically active will participate in resistance training combined with blood flow restriction.
|
Participants will perform six weeks of blood flow restriction (60% occlusion) combined with resistance training at 30% of 1RM.
The intervention comprises five exercises: incline chest press, seated row, leg press, knee extension, and knee flexion.
The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise.
There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle hypertrophy
Time Frame: Baseline and 6 weeks
|
Change in fat-free mass
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: Baseline and 6 weeks
|
Change in 1-repetition maximum
|
Baseline and 6 weeks
|
|
Muscle Power
Time Frame: Baseline and 6 weeks
|
Change in vertical jump score
|
Baseline and 6 weeks
|
|
Muscle Endurance
Time Frame: Baseline and 6 weeks
|
Change in knee extension and flexion
|
Baseline and 6 weeks
|
|
Changes in physical function
Time Frame: Baseline and 6 weeks
|
Changes in short physical performance battery, senior fitness test, and Y-balance test
|
Baseline and 6 weeks
|
|
Changes in blood biomarkers
Time Frame: Baseline and 6 weeks post-intervention and pre and post an acute bout of resistance training at baseline and and after 6 weeks
|
Changes in circulating blood biomarkers
|
Baseline and 6 weeks post-intervention and pre and post an acute bout of resistance training at baseline and and after 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Senechal, PhD, University of New Brunswick
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.