Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596304
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Comparing Vascular Responses to Resistance Exercise with and Without Blood Flow Restriction in Young and Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Macro- and Microvascular Responses to Acute Resistance Exercise with and Without Blood Flow Restriction in Young and Older Adults a Parallel Group Crossover Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLD TIGHT
Brief Summary:
Aging leads to declines in functional capacity and effort tolerance Muscle strength remains stable from ages 25 to 50 but declines significantly after age 60 affecting activities like stair climbing and walking reducing autonomy and independence While muscle atrophy is a significant factor macrovascular endothelial dysfunction also impairs skeletal muscle performance in older adults Nitric oxide NO produced by endothelial cells regulates vascular homeostasis and contractile function NO enhances muscle fiber shortening velocity reduces twitch time-to-peak contraction and increases the rate of force development Aging-related endothelial dysfunction reduces NO availability leading to reduced muscle mass and sarcopenia via decreased skeletal muscle perfusion Increased arterial stiffness disrupts ventricular-vascular coupling reducing cardiac output and contributing to age-related muscle weakness Additionally microvascular function decreases with age contributing to altered physical work perception and reduced function Low capillary density is linked to reduced walking speed in older adults and reduced walking time in peripheral arterial disease patients supporting the microvasculature39s role in functional performance Reduced muscle mass also increases central hemodynamic load impacting arterial stiffness and cardiac function
Resistance training RT is recommended to mitigate aging effects like loss of strength and muscle mass and reduce cardiovascular risk and all-cause mortality Guidelines suggest 1-3 sets of 8-12 repetitions at 60-80 of the individual39s repetition maximum 1RM performed at least twice a week However older adults with osteoarthritis and cardiovascular conditions often cannot tolerate high mechanical stress and are prescribed lower intensity-resistance training LIRT at 40-50 of 1RM typically yielding negligible muscle hypertrophy or strength gains Blood flow restriction BFR training which applies pressure bands to restrict blood flow during LIRT increases muscle volume and strength While BFR shows promise it can cause acute increases in arterial stiffness and blood pressure in older adults necessitating caution in its prescription
This study aims to compare macrovascular and microvascular function responses to acute resistance exercise with and without BFR in young and older adults We hypothesize that older adults will show a more pronounced increase in macrovascular and microvascular dysfunction following resistance exercise compared to younger participants In this parallel group randomized controlled trial participants will be randomly assigned to either LIRT-BFR or high-intensity resistance training HIRT Each participant will attend three sessions a familiarization session and two experimental sessions involving the randomized exercise conditions Measurements of brachial blood pressure heart rate and macrovascular and microvascular function will be taken at rest and during recovery periods post-exercise
Resistance training RT is recommended to mitigate aging effects like loss of strength and muscle mass and reduce cardiovascular risk and all-cause mortality Guidelines suggest 1-3 sets of 8-12 repetitions at 60-80 of the individual39s repetition maximum 1RM performed at least twice a week However older adults with osteoarthritis and cardiovascular conditions often cannot tolerate high mechanical stress and are prescribed lower intensity-resistance training LIRT at 40-50 of 1RM typically yielding negligible muscle hypertrophy or strength gains Blood flow restriction BFR training which applies pressure bands to restrict blood flow during LIRT increases muscle volume and strength While BFR shows promise it can cause acute increases in arterial stiffness and blood pressure in older adults necessitating caution in its prescription
This study aims to compare macrovascular and microvascular function responses to acute resistance exercise with and without BFR in young and older adults We hypothesize that older adults will show a more pronounced increase in macrovascular and microvascular dysfunction following resistance exercise compared to younger participants In this parallel group randomized controlled trial participants will be randomly assigned to either LIRT-BFR or high-intensity resistance training HIRT Each participant will attend three sessions a familiarization session and two experimental sessions involving the randomized exercise conditions Measurements of brachial blood pressure heart rate and macrovascular and microvascular function will be taken at rest and during recovery periods post-exercise
Detailed Description:
In this parallel group crossover randomized trial young and older adults participants will be randomly assigned to 2 experimental conditions a LIRTBFR and HIRT These two conditions were chosen because acute LIREBFR and HIRE have been shown to increase similarly heart rate and blood pressure in older adults Each participant will report to the Laboratory on 3 occasions at least 1 week apart In visit 1 participants will have their body weight and height measured and be evaluated twice for macro- and microvascular function within 30 min at resting condition control After that they will become acquainted with the exercise protocol and determine their one-repetition maximum 1RM for the bilateral leg press exercise and knee extension In visits 2 and 3 participants will perform the experimental conditions in a simple randomized order to which participants will be blinded until arrival at the laboratory
The allocation sequence will be generated by Dr XM using a web-generated simple randomization scheme httpwwwrandomizerorg and placed in sequentially numbered opaque sealed envelopes to ensure concealment of the allocation process and minimize potential biases to researchers and participants delivered to field researchers who will be blind on the day of the first visit
Each session will begin with 15 minutes of supine rest on a cushioned examination table This will be followed by 1 assessment of brachial blood pressure heart rate and microvascular function at rest as measured by finger photoplethysmography Vicorder Berlin Germany Following these assessments participants will engage in one of the previously randomized resistance training experimental conditions for roughly 30 min After that participants immediately return to the examination table and will recover in the supine position for 30 minutes during which brachial blood pressure heart rate and microvascular function will be re-evaluated 5- 30-min intervals into recovery and compared to those at rest Post-exercise time measurements are aimed to characterize the post-exercise biphasic response of the microvascular function
Participants will be instructed to avoid caffeine and alcohol for 24 hours and fully void before the session They will also be advised to avoid vigorous exercise-related activities 24 hours before each session including the familiarization session All evaluations will be led by 4 physiotherapy students per participant 41 with over 30h of training in the evaluation and training protocols During the participant39s time in the laboratory a certified professional in basic life support and automated external defibrillators AEDs will be present at the clinic
Based upon an effect size of 0141 derived from the mean and dispersion response of carotid-radial pulse wave velocity to Non-Autoregulated Blood Flow Restriction resistance exercise 48 participants are required 24 per group matched for sex assuming a 5 alpha error and 20 beta error with a 11 ratio between groups To account for a 10 dropout rate a total of 52 will be recruited
Young adults at Egas Moniz School of Health amp Science will be recruited through Instagram ads and strategically placed posters Interested individuals will use a QR code to access a form with study details and eligibility criteria Eligible participants will receive an electronic informed consent form to sign before their first visit Older adults will be recruited from local senior centers gyms and community programs via email Those who meet the eligibility criteria will receive a printed informed consent form to sign before their first clinic visit
The allocation sequence will be generated by Dr XM using a web-generated simple randomization scheme httpwwwrandomizerorg and placed in sequentially numbered opaque sealed envelopes to ensure concealment of the allocation process and minimize potential biases to researchers and participants delivered to field researchers who will be blind on the day of the first visit
Each session will begin with 15 minutes of supine rest on a cushioned examination table This will be followed by 1 assessment of brachial blood pressure heart rate and microvascular function at rest as measured by finger photoplethysmography Vicorder Berlin Germany Following these assessments participants will engage in one of the previously randomized resistance training experimental conditions for roughly 30 min After that participants immediately return to the examination table and will recover in the supine position for 30 minutes during which brachial blood pressure heart rate and microvascular function will be re-evaluated 5- 30-min intervals into recovery and compared to those at rest Post-exercise time measurements are aimed to characterize the post-exercise biphasic response of the microvascular function
Participants will be instructed to avoid caffeine and alcohol for 24 hours and fully void before the session They will also be advised to avoid vigorous exercise-related activities 24 hours before each session including the familiarization session All evaluations will be led by 4 physiotherapy students per participant 41 with over 30h of training in the evaluation and training protocols During the participant39s time in the laboratory a certified professional in basic life support and automated external defibrillators AEDs will be present at the clinic
Based upon an effect size of 0141 derived from the mean and dispersion response of carotid-radial pulse wave velocity to Non-Autoregulated Blood Flow Restriction resistance exercise 48 participants are required 24 per group matched for sex assuming a 5 alpha error and 20 beta error with a 11 ratio between groups To account for a 10 dropout rate a total of 52 will be recruited
Young adults at Egas Moniz School of Health amp Science will be recruited through Instagram ads and strategically placed posters Interested individuals will use a QR code to access a form with study details and eligibility criteria Eligible participants will receive an electronic informed consent form to sign before their first visit Older adults will be recruited from local senior centers gyms and community programs via email Those who meet the eligibility criteria will receive a printed informed consent form to sign before their first clinic visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None