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High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players

Primary Purpose

Hypertrophy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
Department of Public Health, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertrophy focused on measuring The focus is blood flow restricted exercise

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age >= 18 years
  • Ds
  • 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

Exclusion Criteria:

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

Sites / Locations

  • Dept. of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RT + BFRE

RT

Arm Description

High intensity Resistance training combined with Blood Flow

Resistance training alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Lean body mass
Change in lean body mass assessed by Dual Energy X-ray Absorptiometry

Full Information

First Posted
November 17, 2020
Last Updated
February 10, 2021
Sponsor
Department of Public Health, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04750694
Brief Title
High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
Official Title
High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Department of Public Health, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy
Keywords
The focus is blood flow restricted exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RT + BFRE
Arm Type
Experimental
Arm Description
High intensity Resistance training combined with Blood Flow
Arm Title
RT
Arm Type
Active Comparator
Arm Description
Resistance training alone
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Maximal Muscle Strength
Description
Change in 1 RM (repetition maximum) muscle strength in back squat
Time Frame
Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.
Secondary Outcome Measure Information:
Title
Change in Lean body mass
Description
Change in lean body mass assessed by Dual Energy X-ray Absorptiometry
Time Frame
Baseline measurements at week 1 and post intervention at week 10.
Other Pre-specified Outcome Measures:
Title
Jump Performance
Description
Change in jump height. Change in vertical jump height (in cm, with Chronojump Linear Encoder Kit). Participants will perform a counter movement jump and jump as high as possible. The jump height will be recorded.
Time Frame
Baseline measurements at week 1 and post intervention at week 10.
Title
Sprint performance
Description
Sprint performance. Change in sprint time (in seconds, with Witt speed gates). Participant will perform a 30-meter sprint on an indoor handball court. The time to perform a 30-meter sprint will be recorded.
Time Frame
Baseline measurements at week 1 and post intervention at week 10.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Ds 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 Exclusion Criteria: Elevated blood pressure (>140/90) Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Lønbro, PhD
Phone
004521600410
Email
loenbro@ph.au.dk
Facility Information:
Facility Name
Dept. of Public Health
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Lønbro, PhD
Phone
21600410
Email
loenbro@ph.au.dk
First Name & Middle Initial & Last Name & Degree
Esben Madsen, MSc student
First Name & Middle Initial & Last Name & Degree
Mikkel Garbrecht, MSc student

12. IPD Sharing Statement

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High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players

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