NCT06254586

Brief Summary

Partial restriction of blood flow to working muscles during exercise is proven to increase muscle mass and strength even with low-intensity of exercise. Blood Flow Restriction Training (BFRT) is also beneficial to improve the maximum rate of oxygen consumption (VO2max), bone health, and vascular health. Recent studies focus on its effects beyond the musculoskeletal system. Post-exercise hypotension is a known acute physiological response that happens after intense exercise. Early studies demonstrated BFRT might amplify the acute hypotensive effects with low intensity of exercise. However, it's not clear what type of exercise would help to lower blood pressure when it is combined with BFRT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

February 3, 2024

Last Update Submit

February 3, 2024

Conditions

Keywords

Blood flow Restriction TrainingBlood PressureHeart RateMean Arterial PressureMuscle Girth

Outcome Measures

Primary Outcomes (24)

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    Baseline

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    After 1 minute

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    After 3 minutes

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    After 5 minutes

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    After 15 minutes

  • Heart rate

    The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.

    After 30 minutes

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    Baseline

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 1 minute

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 3 minutes

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 5 minutes

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 15 minutes

  • Blood pressure

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 30 minutes

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    Baseline

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 1 minute

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 3 minutes

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 5 minutes

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 15 minutes

  • Mean arterial pressure

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

    After 30 minutes

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    Baseline

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    After 1 minute

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    After 3 minutes

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    After 5 minutes

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    After 15 minutes

  • Muscle girth

    For biceps measurement, the individual should flex their arm at a 90-degree angle. Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight. Record the measurement in inches or centimeters.

    After 30 minutes

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

This group received a single session of low-intensity cycling for 20 minutes.

Procedure: Aerobic exercises

Resisted exercises

ACTIVE COMPARATOR

This group received four sets of 15 repetitions of knee extension, hamstring curls, and standing calf raises (20-40% 1RM) with a 30 sec to 1 minute rest period between sets.

Procedure: Resisted exercises

Interventions

This group received a single session of low-intensity cycling for 20 minutes. A period of reperfusion (3 to 5 minutes) were provided in both groups after 10 minutes of exercise training by deflating the BFR cuffs. The cuffs were inflated after 5 minutes of reperfusion, and the exercises were completed in both groups.

Aerobic exercise

This group received four sets of 15 repetitions of knee extension, hamstring curls, and standing calf raises (20-40% 1RM) with 30 sec to 1 minute rest period between sets. A period of reperfusion (3 to 5 minutes) were provided in both groups after 10 minutes of exercise training by deflating the BFR cuffs. The cuffs were inflated after 5 minutes of reperfusion, and the exercises were completed in both groups.

Resisted exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults of both gender, between the ages of 18 and 35 years
  • Adults who are not participating in any regular exercise/fitness programmes for the last three months

You may not qualify if:

  • Adults with previous history of cardiovascular diseases, or with pathological changes in ECG
  • Adults with concomitant illness such as diabetes, hypertension, or kidney diseases
  • Chronic smokers or alcoholics
  • Those with recent history of injury to lower limbs or with implants in lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gopal Nambi, PhD

    Prince Sattam Bin Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2024

First Posted

February 12, 2024

Study Start

April 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations