NCT04854356

Brief Summary

The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise (HIIE) on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. Participants were randomized to three groups. Intervention was conducted for 12 weeks with 2 sessions per week. During intervention, all groups conducted HIEE on cycle ergometer with or without BFR. Assessments were conducted before the intervention, on the 6th week of intervention and after the intervention. Assessments included physical characteristics, aerobic and anaerobic capacity, lower limb biomechanics during single-leg landing and isokinetic knee strength.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

April 15, 2021

Last Update Submit

April 17, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change of aerobic capacity from baseline to post-intervention

    Maximum oxygen consumption was measured during Astrand protocol

    12 weeks

  • Change of anaerobic capacity from baseline to post-intervention

    Maximum power was measured during Wingate test protocol

    12 weeks

  • Change of muscular strength from baseline to post-intervention

    The strength of the thigh muscle groups was measured using isokinetic device

    12 weeks

  • Change of knee joint moments from baseline to post-intervention

    Biomechanical data measured during single-leg landing test

    12 weeks

Study Arms (3)

HIE with BFR during exercise phase

EXPERIMENTAL

BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise

Other: Exercise with blood flow restriction (BFR)

HIE with BFR during interval phase

ACTIVE COMPARATOR

BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each during the interval

Other: Exercise with blood flow restriction (BFR)

HIE without BFR

NO INTERVENTION

Cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise

Interventions

All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied.

HIE with BFR during exercise phaseHIE with BFR during interval phase

Eligibility Criteria

Age20 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male adults.
  • Age between 20-25.
  • Have normal body mass index (BMI).
  • Physically active (i.e., exercise regularly for at least three times per week) and total score more than 600MET-min/week based on The International Physical Activity Questionnaire (IPAQ).
  • VO2max value above 42 ml/kg/min during cycling test (Above fair VO2max level)(American College of Sports Medicine, 2010).

You may not qualify if:

  • BMI is greater than 25kg/m2.
  • Have exercise-related disorders such as coronary heart disease, peripheral vascular diseases, rhabdomyolysis, respiratory inflammation, or have neurological disorders.
  • Have implanted electrical devices.
  • Have significant cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Shazlin Shaharudin

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shazlin Shaharudin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 22, 2021

Study Start

April 1, 2021

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

All data in the experiment is anonymous and has been stored in SPSS software. Only researchers can view or extract data. Data were shown as grouped data and participants were not individually identified. The data must be password protected, and only the researcher can access all the data. Before taking the photos and wearing a gas collection mask, the researcher had to ask the participants' permission. The three-dimensional video recorded using Qualisys could not identify the respondent as it only captured the reflective marker number's trajectory on the respondent. Data will be published as scientific articles to be shared with other researchers.

Locations