Condition category
Not Applicable
Date applied
17/09/2019
Date assigned
18/09/2019
Last edited
08/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many handball players have shoulder pain while playing handball. The throwing shoulder is vulnerable for injuries due to repetitive throwing and tackles. A recent study demonstrated that it is possible to reduce the problem by more than 25%. Despite this reduction in shoulder problems, less than one-third of the coaches and players would continue using the whole program the next season, because 'the program was too time-consuming'. Shoulder external rotation weakness is assumed to be a risk factor for shoulder injuries in handball. Therefore, the compressed program to increase external rotation strength was developed. The aim of this study is to examine the effect of the new, compressed shoulder external strength program in youth handball.

Who can participate?
Handball players aged 16 to 18 who play in clubs located in or close to Oslo

What does the study involve?
Six female and male youth 16-18 handball teams will be invited to participate in this study. The researchers will randomly allocate within each team to one exercise group and one control group. The exercise program will be implemented after regular handball training three times a week for eight weeks in the intervention group. The program consists of two shoulder external rotation strength exercises with variations and progressions, aimed to increase shoulder external rotation strength. One dedicated physiotherapist will deliver and supervise the program in the teams once or twice a week. The program will take about ten minutes to complete. Both groups will continue doing their regular training.

What are the possible benefits and risks of participating?
Increasing shoulder external rotation strength, which is a risk factor for shoulder injuries in handball, is a possible benefit in the intervention group. All the participants will be offered the training program after the intervention is finished. There are no known risks of participating.

Where is the study run from?
Oslo Sports Trauma Research Center / Norwegian School of Sport Science (Norway)

When is the study starting and how long is it expected to run for?
January 2019 to December 2020

Who is funding the study?
The Oslo Sports Trauma Research Center has been established at the Norwegian School of Sport Sciences through generous grants from the Royal Norwegian Ministry of Culture, the South-Eastern Norway Regional Health Authority, the International Olympic Committee, the Norwegian Olympic Committee & Confederation of Sport, and Norsk Tipping AS

Who is the main contact?
Mrs Hilde Fredriksen
hilde.fredriksen@nih.no

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Hilde Fredriksen

ORCID ID

http://orcid.org/0000-0002-5158-7716

Contact details

Kikkutveien 4b
Oslo
0491
Norway
+47 (0)99709997
hilde.fredriksen@nih.no

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Evaluation of a compressed program for shoulder external rotation strength in handball. A randomized controlled study among adolescent handball players

Acronym

Study hypothesis

The aim of this study is to examine the effect of a new, compressed shoulder ER strength program in handball.

Ethics approval

Approved 17/09/2019, Norwegian regional committee for medical and health research ethics, South East region (REK sør-øst, Pb 1130 Blindern, 0318 Oslo, Norway; Email: rek-sorost@medisin.uio.no), ref: 2019/1301/REK sør-øst

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Only available in Norwegian. Please use the contact details to request a participant information sheet

Condition

Shoulder strength training in healthy adolescent handball players

Intervention

Six female and male youth 16-18 handball teams will be invited to participate in this study. The researchers will conduct single randomization within each team to one exercise group and one control group. The exercise program will be implemented after regular handball training three times a week for eight weeks in the intervention group. The program consists of two shoulder external rotation (ER) strength exercises with variations and progressions, aimed to increase shoulder ER strength. One dedicated physiotherapist will deliver and supervise the program in the teams once or twice a week. The program will take about ten minutes to complete. Both groups will continue doing their regular training.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Shoulder external rotation strength is measured using a handheld dynamometer (MicroFET, Hoggan Health Industries, Salt Lake City, Utah, USA) at baseline and after 8 weeks of intervention

Secondary outcome measures

Shoulder internal rotation strength is measured using a digital goniometer (Easyangle, Meloq AB, Stockholm, Sweden) at baseline and after 8 weeks of intervention

Overall trial start date

01/01/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Handball players
2. Aged 16 to 18 years
3. Play handball in clubs located in or close to Oslo

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

72

Participant exclusion criteria

Teams who participated in a similar study last year

Recruitment start date

23/09/2019

Recruitment end date

13/10/2019

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo Sports Trauma Research Center/ Norwegian School of Sport Science
Sognsveien 220
Oslo
0806
Norway

Sponsor information

Organisation

Oslo Sports Trauma Research Center, Norwegian School of Sports Sciences

Sponsor details

Sognsveien 220
Oslo
0863
Norway
+47 (0)23 26 20 00
postmottak@nih.no

Sponsor type

University/education

Website

http://nih.no

Funders

Funder type

Government

Funder name

The Oslo Sports Trauma Research Center has been established at the Norwegian School of Sport Sciences through generous grants from the Royal Norwegian Ministry of Culture, the South-Eastern Norway Regional Health Authority, the International Olympic Committee, the Norwegian Olympic Committee & Confederation of Sport, and Norsk Tipping AS

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish the results in 2020.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Hilde Fredriksen (hilde.fredriksen@nih.no). De-identified raw data will be available from the date the article is published. The data will be available for meta-analyses by researchers doing the same type of studies, looking at shoulder strength in athletes.

Intention to publish date

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/10/2019: Trial's existence confirmed by ethics committee. 18/09/2019: Uploaded protocol 18 September 2019 (not peer reviewed)