Athletic InjuriesNCT02842008
Effects of a Therapeutic Exercise Program for Injuries Prevention in Wheelchair Basketball (WB) Players
A study testing Exercise group in people with Athletic Injuries and Shoulder Pain, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball players. About the 85% of this population had shoulder pain in some moment of their life. Some studies suggest that exercise is an important tool as an element to treat and prevent shoulder injuries. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Athletic Injuries, Shoulder Pain, Shoulder Injury
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Players belonging to the male and female preselection Spanish wheelchair basketball national team.
- Have the federal license at the Spanish Sport Federation for People with Physical Disabilities available at the time of the study (2015-2016 season).
- For players using wheelchair for daily activities, to use the manual wheelchair at least for 3 hours a day and 6 hours of wheelchair basketball training per week.
- For players not using wheelchair for daily activities, to use the manual wheelchair at least for 6 hours of wheelchair basketball training per week.
- Use wheelchair at least one year before the study and at least one year of experience in the sport competition.
- Acceptance of informed consent.
Who cannot join
- History of acute injuries in the post-surgical process or dislocation along the year before the study. These conditions may affect the effective of the exercise intervention.
- Differential diagnosis as acute injuries at cervical region and recent traumatic injury in shoulder one year before the study. The exercise program may not be appropriate for these conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball players. About the 85% of this population had shoulder pain in some moment of their life. Some studies suggest that exercise is an important tool as an element to treat and prevent shoulder injuries. For that reason, an intervention program would be a useful tool for prevent shoulder injuries in this population.
The purpose of this study is determine the effects of therapeutic exercise program wheelchair basketball players, in order to prevent shoulder injuries.
Read the detailed description
The hypothesis of the study was that the exercise program was effective to prevent shoulder injuries in this population.
- Conditions
- Athletic Injuries, Shoulder Pain, Shoulder Injury
- Being tested
- Exercise group
- Keywords
- Exercise Therapy, Shoulder pain, Shoulder injuries, Shoulder function, Prevention, Wheelchair users
- Medical subject headings
- Athletic Injuries, Shoulder Pain, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
This group will receive a home exercise program of shoulder based on mobility, strength and strengthening exercises, lasting 10 weeks, 3 times per weeks. The target dose use for mobility consisted in 8 repetitions for each 4 movements, for strengthening using resistive bands, 3 sets (including 5 exercises) of 10 repetitions with a 45 second rest between sets and 5 repetitions for each 5 strength with a 30 second rest and general protocol of postural hygiene. The instructional of the program is 30 minutes each day during the time of the study (10 weeks) with a screening about the exercise program and the daily activities performed every 4 weeks. Physiotherapist provided support to subjects through email along 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Wheelchair basketball players participating in home therapeutic exercise program that use the protocol of postural hygiene. Receives: Behavioral: Exercise group |
| Control group | No intervention | Wheelchair basketball players that not participate in home therapeutic exercise program and use a protocol of postural hygiene provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline shoulder pain at 10 weeks
The presence of shoulder pain will be measured at the beginning and at 10 weeks with "Shoulder Pain Index for Wheelchair Basketball (SPI-WB)" (submitting).
Measured: Baseline and at 10 weeks
Secondary outcomes (9)
Neer test
Neer's Test assesses for possible rotator cuff impingement. Pain is a positive test.
Measured: Baseline and at 10 weeks
Hawkins-Kennedy test
Hawkins-Kennedy's test indicative a possible impingement between the greater tuberosity of the humerus against the coraco- humeral ligament.
Measured: Baseline and at 10 weeks
Jobe test
Jobe's test assesses for possible supraspinatus weakness and/or impingement.
Measured: Baseline and at 10 weeks
Patte test
Patte's test measure for possible infraspinatus and teres minor weakness and/or impingement.
Measured: Baseline and at 10 weeks
Shoulder range of motion
The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric at the beginning and at 10 weeks.
Measured: Baseline and at 10 weeks
Players´ adherence to the exercise program
Players will complete a questionnaire rating their adherence to the exercise program.
Measured: At 4 and 8 weeks
Players´ self-efficacy to the exercise program
Players will complete a questionnaire about the self-efficacy according to the exercise program.
Measured: Baseline
Players adherence to the protocol of postural hygiene.
Players will complete a follow-up questionnaire rating their adherence to the protocol of postural hygiene.
Measured: At 4 and 8 weeks
Activities performed outside of the training and exercise program.
Players will be complete a follow-up questionnaire about the activities performed outside of the training and exercise program.
Measured: At 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleky García Gómez, Universidad Politecnica de Madrid
- Investigators
- Javier Pérez Tejero, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842008
- Sponsor's protocol ID
- UPMadrid
- Status last verified
- Nov 2017
- First submitted
- 6 Jun 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Therapeutic Exercise Program for Injuries Prevention in Wheelchair Basketball (WB) Players
- ClinicalTrials.gov ID
- NCT02842008
- Acronym / sponsor ID
- UPMadrid
- Conditions
- Athletic Injuries, Shoulder Pain, Shoulder Injury
- Keywords
- Exercise Therapy, Shoulder pain, Shoulder injuries, Shoulder function, Prevention, Wheelchair users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball players. About the 85% of this population had shoulder pain in some moment of their life. Some studies suggest that exercise is an important tool as an element to treat and prevent shoulder injuries. For that reason, an intervention program would be a useful tool for prevent shoulder injuries in this population.
The purpose of this study is determine the effects of therapeutic exercise program wheelchair basketball players, in order to prevent shoulder injuries.
Detailed description
The hypothesis of the study was that the exercise program was effective to prevent shoulder injuries in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupWheelchair basketball players participating in home therapeutic exercise program that use the protocol of postural hygiene. |
| Control group | No intervention | –Wheelchair basketball players that not participate in home therapeutic exercise program and use a protocol of postural hygiene provided. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Players belonging to the male and female preselection Spanish wheelchair basketball national team.
- Have the federal license at the Spanish Sport Federation for People with Physical Disabilities available at the time of the study (2015-2016 season).
- For players using wheelchair for daily activities, to use the manual wheelchair at least for 3 hours a day and 6 hours of wheelchair basketball training per week.
- For players not using wheelchair for daily activities, to use the manual wheelchair at least for 6 hours of wheelchair basketball training per week.
- Use wheelchair at least one year before the study and at least one year of experience in the sport competition.
Key exclusion criteria (2 listed)
- History of acute injuries in the post-surgical process or dislocation along the year before the study. These conditions may affect the effective of the exercise intervention.
- Differential diagnosis as acute injuries at cervical region and recent traumatic injury in shoulder one year before the study. The exercise program may not be appropriate for these conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupThis group will receive a home exercise program of shoulder based on mobility, strength and strengthening exercises, lasting 10 weeks, 3 times per weeks. The target dose use for mobility consisted in 8 repetitions for each 4 movements, for strengthening using resistive bands, 3 sets (including 5 exercises) of 10 repetitions with a 45 second rest between sets and 5 repetitions for each 5 strength with a 30 second rest and general protocol of postural hygiene. The instructional of the program is 30 minutes each day during the time of the study (10 weeks) with a screening about the exercise program and the daily activities performed every 4 weeks. Physiotherapist provided support to subjects through email along 10 weeks. | Behavioural | Exercise group |
Primary outcome
Change from baseline shoulder pain at 10 weeks
Time frame: Baseline and at 10 weeks
The presence of shoulder pain will be measured at the beginning and at 10 weeks with "Shoulder Pain Index for Wheelchair Basketball (SPI-WB)" (submitting).
9 secondary outcomes
Neer test
Time frame: Baseline and at 10 weeks
Hawkins-Kennedy test
Time frame: Baseline and at 10 weeks
Jobe test
Time frame: Baseline and at 10 weeks
Patte test
Time frame: Baseline and at 10 weeks
Shoulder range of motion
Time frame: Baseline and at 10 weeks
Players´ adherence to the exercise program
Time frame: At 4 and 8 weeks
Players´ self-efficacy to the exercise program
Time frame: Baseline
Players adherence to the protocol of postural hygiene.
Time frame: At 4 and 8 weeks
Activities performed outside of the training and exercise program.
Time frame: At 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Pérez Tejero, PhD study director
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Athletic Injuries and Shoulder Pain, run by Universidad Politecnica de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline shoulder pain at 10 weeks (time frame: Baseline and at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.