NCT06912867

Brief Summary

The aim of this study is to evaluate the effects of blood flow restriction (BFR) exercises on lower extremity muscle strength, muscle thickness, and sport-specific motivation in adolescent elite male canoe athletes. Participants aged 15-18 years will perform low-intensity resistance exercises supported by BFR twice a week for 8 weeks. Pre- and post-intervention measurements will include one-repetition maximum (1RM) for muscle strength, ultrasound for muscle thickness, and the Sport Motivation Scale for assessing motivation. Findings are expected to contribute to optimizing training protocols for canoe athletes and to reveal the potential performance-enhancing role of BFR training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

May 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

March 27, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

Blood Flow RestrictionMuscle StrengthAdolescent AthletesCanoe SprintSport Motivation

Outcome Measures

Primary Outcomes (3)

  • Lower Extremity Muscle Strength (Peak Torque, Nm) - measured via isokinetic dynamometry

    Muscle strength of the quadriceps and hamstring muscles was assessed using an isokinetic dynamometer (Biodex System 4) at angular velocities of 60°/s and 300°/s. Peak torque (in Newton-meters) was recorded for both right and left lower limbs. Measurements were conducted at baseline and after the 8-week intervention period by a blinded physiotherapist.

    Baseline (Week 0) and Post-intervention (Week 8)

  • Muscle Thickness (mm) - measured via ultrasound

    Muscle thickness and cross-sectional area of the quadriceps femoris and hamstring muscle groups were evaluated using B-mode ultrasound imaging (Mindray DP-10). Measurements were taken bilaterally from standardized anatomical landmarks in a resting position. The assessment was performed by a blinded sports medicine physician at baseline and after 8 weeks of training.

    Baseline (Week 0) and Post-intervention (Week 8)

  • Sport-Specific Motivation Score - measured using the Sport Motivation Scale (validated Turkish version)

    Sport-specific motivation levels will be assessed using the Turkish-validated version of the Sport Motivation Scale-II. The scale consists of 18 items rated on a 7-point Likert scale ranging from 1 (Does not correspond at all) to 7 (Corresponds exactly). Total scores range from 18 to 126, with higher scores indicating greater overall sport motivation. The scale includes three subdimensions relevant to this study: Motivation to Show Strength Motivation to Approach Success Motivation to Avoid Failure Subscale scores are calculated as the mean of related items. Higher subscale scores indicate a stronger level of that specific motivational trait.

    Baseline (Week 0) and Post-intervention (Week 8)

Study Arms (2)

BFR Training Group

EXPERIMENTAL

Participants performed supervised low-load resistance training with BFR using KAATSU C3 equipment twice a week for 8 weeks.

Behavioral: Blood Flow Restriction (BFR) Exercise Program

Control Group

NO INTERVENTION

Participants in this group continued their standard canoe training program without additional blood flow restriction exercises.

Interventions

Participants performed supervised low-load resistance training with BFR using KAATSU C3 equipment twice a week for 8 weeks.

BFR Training Group

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male athletes aged between 15 and 18 years
  • Registered elite-level canoe athletes actively training within a national program
  • Minimum of 2 years of canoe sport experience
  • Voluntary participation with informed consent (for minors: parental/guardian consent)
  • Medically cleared to participate in physical training and testing

You may not qualify if:

  • Existing orthopedic injuries or musculoskeletal disorders affecting lower extremities
  • History of cardiovascular, neurological, or metabolic diseases
  • Non-compliance with the training protocol during the study
  • Participation in any other structured strength training program during the study period
  • Use of medications or supplements affecting muscle performance or motivation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burcin Ugur Tosun

Famagusta, 99010, Cyprus

Location

Study Officials

  • burcin ugur tosun, PHD

    "Bandırma Onyedi Eylül University, Faculty of Health Sciences"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors were blinded to group allocation
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned into two groups using block randomization: an intervention group receiving blood flow restriction (BFR) training and a control group continuing regular training without BFR. Both groups followed their respective training protocols over an 8-week period. Outcomes were assessed pre- and post-intervention by blinded evaluators.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator PhD Physiotherapist Burcin Ugur Tosun

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 6, 2025

Study Start

May 10, 2024

Primary Completion

October 15, 2024

Study Completion

January 20, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations