Aerobic CapacityNCT07114835

Low-Intensity BFR Cycling: Impact on VO₂Max and Muscle Adaptations

A study testing Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP) and Cycling Exercise (40 min at 40% VO₂max) in people with Aerobic Capacity and Blood Flow Restriction (BFR) Training Effects, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for: Aerobic Capacity, Blood Flow Restriction (BFR) Training Effects, Blood Flow Restriction Exercise
What is being tested?: Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP) and Cycling Exercise (40 min at 40% VO₂max)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Dec 2023to 5 Mar 2024
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 24 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Individuals aged between 18-24 years,
Individuals without any health problems,
Individuals who do not actively participate in sports,
Individuals who marked all items as no on the H+cuff participant information form,
Individuals who have not had a sports injury that would prevent them from participating in sports in the last 6 months,

Who cannot join

history of lower extremity injury, respiratory disorders and refusal to participate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Faculty of Sport Science
Kahramanmaraş, Onikişubat, 46050

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Low-Intensity Cycling Exercise Combined With Blood Flow Restriction on VO2max, Muscle Strength, and Muscle Thickness in Physically Active Individuals

This study aims to investigate the effects of low-intensity cycling exercise combined with blood flow restriction (BFR) on maximal oxygen consumption (VO₂max), muscle strength, and muscle thickness in sedentary adult males. Participants will be randomly assigned to three groups: (1) a cycling exercise group performing 40 minutes of cycling at 40% VO₂max, (2) a cycling with blood flow restriction group performing 15 minutes of cycling at 40% VO₂max with limb occlusion pressure at 60-80%, and (3) a control group following a shorter cycling protocol. Muscle thickness, isokinetic knee strength, and VO₂max will be measured before and after the 9-week intervention. The study is designed to evaluate whether short-duration, low-intensity cycling with BFR can induce physiological adaptations comparable to traditional longer-duration cycling protocols.

Read the detailed description

This study is designed to examine the effects of low-intensity cycling exercise combined with blood flow restriction (BFR) on aerobic capacity (VO₂max), isokinetic knee strength, and muscle thickness in sedentary male adults. Traditional methods for improving aerobic capacity and muscle strength often involve high-intensity or long-duration training protocols. However, such protocols may not be feasible for all individuals, particularly during rehabilitation, periods of detraining, or in populations with limited exercise tolerance.

Blood flow restriction training has gained attention as a promising strategy to elicit muscular and cardiovascular adaptations using lower intensities. The technique involves applying individualized limb occlusion pressure (LOP) via pneumatic cuffs during exercise to partially restrict arterial inflow and fully restrict venous outflow. This restriction is thought to create a hypoxic environment and increase metabolic stress, which may enhance the recruitment of fast-twitch muscle fibers and stimulate physiological adaptations.

In this randomized controlled trial, participants are allocated to one of three groups: a standard cycling exercise group (40 minutes at 40% VO₂max), a BFR cycling group (15 minutes at 40% VO₂max with 60-80% LOP), and a control group (15 minutes at 40% VO₂max without BFR). All exercise sessions are performed three times per week for nine weeks. The LOP is adjusted across the training period to progressively increase the stimulus in the BFR group.

Baseline and post-intervention assessments include measurements of body height and weight, ultrasound-based muscle thickness, isokinetic knee strength testing, and graded exercise testing for VO₂max. The goal is to determine whether low-intensity, short-duration cycling with BFR can serve as a practical and effective alternative to longer-duration exercise programs.

Conditions: Aerobic Capacity, Blood Flow Restriction (BFR) Training Effects, Blood Flow Restriction Exercise, Muscle Strengh, Isokinetic, VO2max
Being tested: Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP), Cycling Exercise (40 min at 40% VO₂max), Short-Duration Cycling Control (15 min at 40% VO₂max)
Keywords: Blood flow restriction, aerobic capacity, VO2max, muscle strength, muscle thickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP)Procedure or surgery
Also called BFR Cycling, Low-Intensity Cycling + BFR, CBFR
This intervention involves low-intensity cycling exercise at 40% of VO₂max performed on an electronically braked Astrand cycle ergometer for 15 minutes per session. During each session, pneumatic cuffs (10 cm wide, manually adjustable) are applied to the upper thighs to restrict blood flow. Individualized limb occlusion pressure (LOP) is determined via Doppler ultrasound and set progressively at 60% (weeks 1-4), 70% (weeks 5-7), and 80% (weeks 8-9). Sessions are conducted three times per week over a 9-week period. The aim is to simulate the physiological effects of high-intensity training using a low-intensity protocol.
Cycling Exercise (40 min at 40% VO₂max)Procedure or surgery
Also called CEG, Standard Low-Intensity Cycling, Long-duration Cycling
This intervention involves standard low-intensity cycling exercise at 40% of the participant's VO₂max, performed for 40 minutes per session on an electronically braked Astrand cycle ergometer. Sessions are conducted three times per week for a total duration of 9 weeks. This group does not receive any blood flow restriction or external loading. The aim is to observe the effects of traditional low-intensity, long-duration aerobic exercise on VO₂max, muscle strength, and muscle thickness.
Short-Duration Cycling Control (15 min at 40% VO₂max)Procedure or surgery
Also called Control Group Cycling, CG Short Cycling, No BFR
This intervention involves low-intensity cycling exercise at 40% of VO₂max performed for 15 minutes per session, using an electronically braked Astrand cycle ergometer. Participants exercise three times per week for 9 weeks. No blood flow restriction is applied. The aim of this control condition is to match the duration of the BFR intervention while omitting the occlusion component, to isolate the effect of BFR.

Study groups in NCT07114835
Study group	Role	What they receive
Cycling Exercise - 40 min at 40% VO₂max	Experimental	Participants in this group perform low-intensity cycling exercise at 40% of their VO₂max for 40 minutes per session, three times per week, over a 9-week period. All sessions are conducted on an electronically braked Astrand cycle ergometer. This group does not receive blood flow restriction. Receives: Procedure: Cycling Exercise (40 min at 40% VO₂max)
Control - 15 min Cycling at 40% VO₂max	Active comparator	Participants in the control group perform cycling exercise at 40% of their VO₂max for 15 minutes per session, three times per week for 9 weeks. The exercise is performed on an electronically braked Astrand cycle ergometer. No blood flow restriction or additional intervention is applied in this group. Receives: Procedure: Short-Duration Cycling Control (15 min at 40% VO₂max)
Cycling + BFR - 15 min at 40% VO₂max with 60-80% LOP	Experimental	Participants in this group perform cycling exercise at 40% of their VO₂max for 15 minutes per session, three times per week for 9 weeks. During each session, pneumatic cuffs are applied to the proximal thighs to restrict blood flow, with individualized limb occlusion pressure (LOP) set at 60% in weeks 1-4, 70% in weeks 5-7, and 80% in weeks 8-9. The exercise is performed on an electronically braked Astrand cycle ergometer. Receives: Procedure: Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximal Oxygen Consumption (VO₂max, L/min)
Absolute VO₂max will be measured during a graded cycling exercise test using a breath-by-breath gas analyzer.
Measured: Baseline and Post-test (Week 9)
Change in Relative VO₂max (ml/kg/min)
VO₂max will also be reported relative to body weight using standard calculation: (VO₂max ÷ body weight).
Measured: Baseline and Post-test (Week 9)

Secondary outcomes (4)

Change in Muscle Thickness (Rectus Femoris, Vastus Lateralis, Biceps Femoris)
Muscle thickness will be measured using B-mode ultrasonography with linear probe at specified anatomical landmarks.
Measured: Baseline and Post-test (Week 9)
Change in Peak Torque (Isokinetic Knee Strength, 60°/s and 180°/s)
Isokinetic knee extension and flexion strength will be measured using an isokinetic dynamometer at angular velocities of 60°/s and 180°/s.
Measured: Baseline and Post-test (Week 9)
Change in Respiratory Exchange Ratio (RER)
RER will be recorded during the maximal exercise test as the ratio of carbon dioxide output to oxygen uptake (VCO₂/VO₂).
Measured: Baseline and Post-test (Week 9)
Change in Maximal Heart Rate (MHR)
Maximal heart rate will be recorded during the graded exercise test.
Measured: Baseline and Post-test (Week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20235 Mar 2024

First posted11 Aug 2025
Study start1 Dec 2023
Primary completion5 Mar 2024
Study completion5 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Aerobic CapacityStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Initially, 30 male volunteers who were not actively engaged in sports were recruited for the study. After applying the exclusion criteria, which included a history of lower extremity injury (n = 4), respiratory disorders (n = 1) and refusal to participate (n = 1), a total of six individuals were excluded in the initial phase. Thus, the study commenced with 24 male participants. Each group consisted of eight participants who completed the protocol and final post-tests were conducted and analysed accordingly. All participants were healthy individuals who did not engage in regular physical activity. The study involved three exercise groups: The Control Group (CG); the Cycling with Blood Flow Restriction Group (CBFRG); Cycling Exercise Group (CEG)
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07114835
Sponsor's protocol ID: BFR-Cycling-2025
Status last verified: Aug 2025
First submitted: 30 Jun 2025
Last updated: 11 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: It is planned to share the results of the training so that they can see their own development and the increase in their performance.

Publications

Bennett H, Slattery F. Effects of Blood Flow Restriction Training on Aerobic Capacity and Performance: A Systematic Review. J Strength Cond Res. 2019 Feb;33(2):572-583. doi: 10.1519/JSC.0000000000002963.
PubMed 30531417
Gao Z, Li Y, Zhang J, Li L, Wang T, Wang X, Wang H. Effects of aerobic training with blood flow restriction on aerobic capacity, muscle strength, and hypertrophy in young adults: a systematic review and meta-analysis. Front Physiol. 2025 Jan 7;15:1506386. doi: 10.3389/fphys.2024.1506386. eCollection 2024.
PubMed 39839525
Zeng Q, Wang L, Zhang Y, Wei H, He Z. Effects of blood flow restriction cycling training on body composition and blood lipids in overweight male college students. Front Physiol. 2022;12:792756. doi:10.3389/fphys.2021.792756 22.
Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
PubMed 16339340
Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010.
PubMed 24149640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effects of Low-Intensity Cycling Exercise Combined With Blood Flow Restriction on VO2max, Muscle Strength, and Muscle Thickness in Physically Active Individuals
ClinicalTrials.gov ID: NCT07114835
Acronym / sponsor ID: BFR-Cycling-2025
Conditions: Aerobic Capacity, Blood Flow Restriction (BFR) Training Effects, Blood Flow Restriction Exercise, Muscle Strengh, Isokinetic, VO2max
Keywords: Blood flow restriction, aerobic capacity, VO2max, muscle strength, muscle thickness
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 5 Mar 2024 (actual)
Study completion: 5 Mar 2024 (actual)
First posted: 11 Aug 2025 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3
Model description: Initially, 30 male volunteers who were not actively engaged in sports were recruited for the study. After applying the exclusion criteria, which included a history of lower extremity injury (n = 4), respiratory disorders (n = 1) and refusal to participate (n = 1), a total of six individuals were excluded in the initial phase. Thus, the study commenced with 24 male participants. Each group consisted of eight participants who completed the protocol and final post-tests were conducted and analysed accordingly. All participants were healthy individuals who did not engage in regular physical activity. The study involved three exercise groups: The Control Group (CG); the Cycling with Blood Flow Restriction Group (CBFRG); Cycling Exercise Group (CEG)

Arm	Type	Receives
Cycling Exercise - 40 min at 40% VO₂max	Experimental	Procedure: Cycling Exercise (40 min at 40% VO₂max)Participants in this group perform low-intensity cycling exercise at 40% of their VO₂max for 40 minutes per session, three times per week, over a 9-week period. All sessions are conducted on an electronically braked Astrand cycle ergometer. This group does not receive blood flow restriction.
Control - 15 min Cycling at 40% VO₂max	Active comparator	Procedure: Short-Duration Cycling Control (15 min at 40% VO₂max)Participants in the control group perform cycling exercise at 40% of their VO₂max for 15 minutes per session, three times per week for 9 weeks. The exercise is performed on an electronically braked Astrand cycle ergometer. No blood flow restriction or additional intervention is applied in this group.
Cycling + BFR - 15 min at 40% VO₂max with 60-80% LOP	Experimental	Procedure: Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP)Participants in this group perform cycling exercise at 40% of their VO₂max for 15 minutes per session, three times per week for 9 weeks. During each session, pneumatic cuffs are applied to the proximal thighs to restrict blood flow, with individualized limb occlusion pressure (LOP) set at 60% in weeks 1-4, 70% in weeks 5-7, and 80% in weeks 8-9. The exercise is performed on an electronically braked Astrand cycle ergometer.

Who may qualify

Ages: 18 to 24 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Individuals aged between 18-24 years,
Individuals without any health problems,
Individuals who do not actively participate in sports,
Individuals who marked all items as no on the H+cuff participant information form,
Individuals who have not had a sports injury that would prevent them from participating in sports in the last 6 months,

Key exclusion criteria (1 listed)

history of lower extremity injury, respiratory disorders and refusal to participate

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
Cycling with Blood Flow Restriction (15 min at 40% VO₂max with 60-80% LOP)Also: BFR Cycling, Low-Intensity Cycling + BFR, CBFRThis intervention involves low-intensity cycling exercise at 40% of VO₂max performed on an electronically braked Astrand cycle ergometer for 15 minutes per session. During each session, pneumatic cuffs (10 cm wide, manually adjustable) are applied to the upper thighs to restrict blood flow. Individualized limb occlusion pressure (LOP) is determined via Doppler ultrasound and set progressively at 60% (weeks 1-4), 70% (weeks 5-7), and 80% (weeks 8-9). Sessions are conducted three times per week over a 9-week period. The aim is to simulate the physiological effects of high-intensity training using a low-intensity protocol.	Procedure or surgery	Cycling + BFR - 15 min at 40% VO₂max with 60-80% LOP
Cycling Exercise (40 min at 40% VO₂max)Also: CEG, Standard Low-Intensity Cycling, Long-duration CyclingThis intervention involves standard low-intensity cycling exercise at 40% of the participant's VO₂max, performed for 40 minutes per session on an electronically braked Astrand cycle ergometer. Sessions are conducted three times per week for a total duration of 9 weeks. This group does not receive any blood flow restriction or external loading. The aim is to observe the effects of traditional low-intensity, long-duration aerobic exercise on VO₂max, muscle strength, and muscle thickness.	Procedure or surgery	Cycling Exercise - 40 min at 40% VO₂max
Short-Duration Cycling Control (15 min at 40% VO₂max)Also: Control Group Cycling, CG Short Cycling, No BFRThis intervention involves low-intensity cycling exercise at 40% of VO₂max performed for 15 minutes per session, using an electronically braked Astrand cycle ergometer. Participants exercise three times per week for 9 weeks. No blood flow restriction is applied. The aim of this control condition is to match the duration of the BFR intervention while omitting the occlusion component, to isolate the effect of BFR.	Procedure or surgery	Control - 15 min Cycling at 40% VO₂max

Primary outcome

Change in Maximal Oxygen Consumption (VO₂max, L/min)
Time frame: Baseline and Post-test (Week 9)
Absolute VO₂max will be measured during a graded cycling exercise test using a breath-by-breath gas analyzer.
Change in Relative VO₂max (ml/kg/min)
Time frame: Baseline and Post-test (Week 9)
VO₂max will also be reported relative to body weight using standard calculation: (VO₂max ÷ body weight).

4 secondary outcomes

Change in Muscle Thickness (Rectus Femoris, Vastus Lateralis, Biceps Femoris)
Time frame: Baseline and Post-test (Week 9)
Change in Peak Torque (Isokinetic Knee Strength, 60°/s and 180°/s)
Time frame: Baseline and Post-test (Week 9)
Change in Respiratory Exchange Ratio (RER)
Time frame: Baseline and Post-test (Week 9)
Change in Maximal Heart Rate (MHR)
Time frame: Baseline and Post-test (Week 9)

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 11 Aug 2025.
Background: PubMed 30531417Bennett H, Slattery F. Effects of Blood Flow Restriction Training on Aerobic Capacity and Performance: A Systematic Review. J Strength Cond Res. 2019 Feb;33(2):572-583. doi: 10.1519/JSC.0000000000002963.
Background: PubMed 39839525Gao Z, Li Y, Zhang J, Li L, Wang T, Wang X, Wang H. Effects of aerobic training with blood flow restriction on aerobic capacity, muscle strength, and hypertrophy in young adults: a systematic review and meta-analysis. Front Physiol. 2025 Jan 7;15:1506386. doi: 10.3389/fphys.2024.1506386. eCollection 2024.
BackgroundZeng Q, Wang L, Zhang Y, Wei H, He Z. Effects of blood flow restriction cycling training on body composition and blood lipids in overweight male college students. Front Physiol. 2022;12:792756. doi:10.3389/fphys.2021.792756 22.
Results publication: PubMed 16339340Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
Results publication: PubMed 24149640Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010.
Individual participant dataSharing planned: Yes. It is planned to share the results of the training so that they can see their own development and the increase in their performance.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 11 Aug 2025. 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 Turkey (Türkiye). 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?

Change in Maximal Oxygen Consumption (VO₂max, L/min) (time frame: Baseline and Post-test (Week 9)). 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?

On the ClinicalTrials.gov record for NCT07114835, which also lists 5 linked publications.

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 11 Aug 2025.