NCT04750694

Brief Summary

Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone. Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

November 17, 2020

Last Update Submit

February 10, 2021

Conditions

Hypertrophy

Keywords

The focus is blood flow restricted exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Maximal Muscle Strength

    Change in 1 RM (repetition maximum) muscle strength in back squat

    Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.

Secondary Outcomes (1)

  • Change in Lean body mass

    Baseline measurements at week 1 and post intervention at week 10.

Other Outcomes (2)

  • Jump Performance

    Baseline measurements at week 1 and post intervention at week 10.

  • Sprint performance

    Baseline measurements at week 1 and post intervention at week 10.

Study Arms (2)

RT + BFRE

EXPERIMENTAL

High intensity Resistance training combined with Blood Flow

Behavioral: Resistance training

RT

ACTIVE COMPARATOR

Resistance training alone

Behavioral: Resistance training

Interventions

Resistance trainingBEHAVIORAL

A full-training programme with high intensity followed by back squat exercise with blood flow restriction. Inflatable cuffs will be placed proximally on both thighs. The cuff pressure will be 50% of individual arterial occlusion pressure and will be maintained during the rest intervals. Participants will perform 30, 15, 15 and 15 repetitions of 30% of 1 Repetition Maximum. Totally 75 repetitions will be performed. 45 seconds rest interval between sets will be given.

RTRT + BFRE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>= 18 years
  • Minimum of 2 years of resistance training experience
  • \>\< Two resistance training sessions each week
  • \>\< three handball sessions each week
  • No injuries that prevent participants to perform test of maximal muscle strength
  • No injuries, that affects the muscle strength or the ability to train

You may not qualify if:

  • Elevated blood pressure (\>140/90)
  • Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Public Health

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Hypertrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Simon Lønbro, PhD

CONTACT

004521600410loenbro@ph.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Associate Professor, PhD

Study Record Dates

First Submitted

November 17, 2020

First Posted

February 11, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

DK(1)