Home ExerciseNCT04434183
Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients
A study testing Exercises of rehabilitation in people with Home Exercise and Quality of Life, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Home Exercise, Quality of Life
- What is being tested?
- Exercises of rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2018to 30 Nov 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain and functional disability at least 6 months
Who cannot join
- Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Comparison of the Effects of Home Exercise Program and Isokinetic Exercise Program on Pain, Muscle Strength, Functionality, Sense of Proprioception and Quality of Life in Subacromial Impingement Syndrome Patients
The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.
Read the detailed description
The study was designed prospectively. A total of 50 patients with subacromial impingement syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were included in the study. Patients were randomly divided into two groups. The first group (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home exercise group, n=25) was given home exercise program. Patients were evaluated before and after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at the level of p\< 0.05.
- Conditions
- Home Exercise, Quality of Life
- Being tested
- Exercises of rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises of rehabilitationDevice
Also called Isokinetic cybex dynamometer
Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
| Study group | Role | What they receive |
|---|---|---|
| isokinetic exercise | Active comparator | The group (isokinetic exercise group, n = 25) was given isokinetic exercise. Receives: Device: Exercises of rehabilitation |
| home exercise | Active comparator | The group(home exercise group, n=25) was given home exercise program. Receives: Device: Exercises of rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of shoulder examination findings
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings. The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.
Measured: 3 months
Assessment of shoulder functions
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght. The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.
Measured: 3 months
Assessment of muscle strenght
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.
Measured: 3 months
Assessment of quality of life
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index. The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.
Measured: 3 months
Assessment of sense of proprioseption
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.
Measured: 3 months
Assessment of shoulder pain
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain. The investigators used to visual analog score for pain that scored from zero to ten.
Measured: 3 months
Assessment of shoulder disability
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability. The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no. Calculation; score = [Yes counts / (Yes counts + No counts)]x100. The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.
Measured: 3 months
Assessment of physical health situation
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation. The investigators used to health evaluated inventory. The inventroy consisting of 20 questions that scored from zero to three per question. Zero point is maximal fine health and 60 points are maximal poor health.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start30 May 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Home ExerciseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- OMER KURU, FULL PROF, Study chair, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434183
- Sponsor's protocol ID
- 851
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.
PubMed 14578662Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.
PubMed 18509791
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Home Exercise Program and Isokinetic Exercise Program on Pain, Muscle Strength, Functionality, Sense of Proprioception and Quality of Life in Subacromial Impingement Syndrome Patients
- ClinicalTrials.gov ID
- NCT04434183
- Acronym / sponsor ID
- 851
- Conditions
- Home Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.
Detailed description
The study was designed prospectively. A total of 50 patients with subacromial impingement syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were included in the study. Patients were randomly divided into two groups. The first group (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home exercise group, n=25) was given home exercise program. Patients were evaluated before and after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at the level of p\< 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isokinetic exercise | Active comparator | Device: Exercises of rehabilitationThe group (isokinetic exercise group, n = 25) was given isokinetic exercise. |
| home exercise | Active comparator | Device: Exercises of rehabilitationThe group(home exercise group, n=25) was given home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shoulder pain and functional disability at least 6 months
Key exclusion criteria (1 listed)
- Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases
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 |
|---|---|---|
| Exercises of rehabilitationAlso: Isokinetic cybex dynamometerCompare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients | Device | home exercise, isokinetic exercise |
Primary outcome
Assessment of shoulder examination findings
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings. The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.
Assessment of shoulder functions
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght. The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.
Assessment of muscle strenght
Time frame: 3 months
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.
Assessment of quality of life
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index. The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.
Assessment of sense of proprioseption
Time frame: 3 months
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.
Assessment of shoulder pain
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain. The investigators used to visual analog score for pain that scored from zero to ten.
Assessment of shoulder disability
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability. The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no. Calculation; score = [Yes counts / (Yes counts + No counts)]x100. The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.
Assessment of physical health situation
Time frame: 3 months
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation. The investigators used to health evaluated inventory. The inventroy consisting of 20 questions that scored from zero to three per question. Zero point is maximal fine health and 60 points are maximal poor health.
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 18 Jun 2020.
- Results publication: PubMed 14578662Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.
- Results publication: PubMed 18509791Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.
- Subacromial Impingement Syndrome: Pathogenesis, Clinical Features, and Examination MethodsLink provided by the sponsor.
- External Impingement of the ShoulderLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
OMER KURU, FULL PROF study chair
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises of rehabilitation in people with Home Exercise and Quality of Life, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 18 Jun 2020. 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 Turkey (Türkiye). 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?
Assessment of shoulder examination findings (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434183, which also lists 2 linked publications.
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 18 Jun 2020.