Hypermobility Syndrome ShoulderNCT03547570
Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
A study testing Progressive heavy shoulder resistance training in people with Hypermobility Syndrome Shoulder and Shoulder Pain Chronic, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypermobility Syndrome Shoulder, Shoulder Pain Chronic
- What is being tested?
- Progressive heavy shoulder resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesDenmark
- Study dates
- 4 May 2018to 6 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
- Men and women aged 18 - 65
- Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men [21, 22] or historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items). In patients with acquired joint limitations (past surgery, wheelchair, amputations) affecting the Beighton score calculation, the assessment of GJH only included a positive 5 part-questionnaire.
- Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either musculoskeletal pain in minimum one shoulder for at least three months or recurrent joint dislocations or joint instability without a reported history of trauma defined as: a) minimum three atraumatic dislocations in same shoulder or minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or b) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.
Who cannot join
- Clinically suspected referred pain from the cervical spine
- Systemic rheumatic diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes)
- Neurological diseases
- Pregnancy or childbirth within the latest year
- Shoulder surgery within the past year
- Inability to speak and understand Danish.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
GP´s and physiotherapists
Esbjerg, Region Syddanmark
GP´s and physiotherapists
Middelfart, Egion of Southern Denmark
GP´s and physiotherapists
Odense, Region Syddanmark
About this study
Official title: Progressive Heavy Shoulder Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms.
Read the detailed description
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms before safely performing a definitive RCT-study in a large cohort. The objectives are to address whether PHSRT is feasible regarding i) patient recruitment and retention, ii) adherence to exercise protocol and its progression levels, iii) completion of objective outcome measures, and iv) registering potential flare up in shoulder symptoms.
Study progression criteria are based on a traffic light system of green (go), amber (amend) and red (stop). Results of these progression criteria will be evaluated by the investigator group, who will recommend amendments that need to be made before proceeding with the definitive RCT.
- Being tested
- Progressive heavy shoulder resistance training
- Keywords
- Joint instability, Hypermobility, Shoulder, Strength training
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive heavy shoulder resistance trainingOther
The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.
| Study group | Role | What they receive |
|---|---|---|
| Heavy shoulder resistance training | Experimental | Progressive heavy shoulder resistance training performed twice a week at the physiotherapy clinic under supervision, while once weekly training at home will be recommended. Receives: Other: Progressive heavy shoulder resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment
Green: Inclusion rate of one patient per general practitioner or physiotherapist every month (approximately n=6-8/month).
Amber: If the recruitment rate falls behind, screening logs and reasons for exclusion will be explored after the first month in order to adjust eligibility criteria (n<6 after first month)
Red: No recruitment after two months
Measured: 4 months
Completion of the outcome measures
Green: 120 minutes for completing all objective outcome measures and at least 67% of patients answering that it was an acceptable duration
Amber: Between 121-150 minutes or between 50-66% of patients answering that it was an acceptable duration
Red: >150 minutes or <50% of patients answering that it was an acceptable duration
Measured: Baseline measures
Patient retention
Green: 10 or more patients show up at 16-weeks follow up
Amber: 6-9 patients show up at 16-weeks follow up
Red: Less than 6 patients show up at 16-weeks follow up
Measured: 4 months
Adherence to training intervention
Green: At least 75% of patients adhering to at least 75% of training sessions
Amber: 50-75% of patients adhering to 50-75% of training sessions
Red: <50% of patients adhering to <50% of training sessions
Measured: 4 months
Adverse events
Green: No or minor adverse events with no patients discontinuing the trial
Amber: Minor or serious adverse events leading to 2 or less patients discontinuing the trial
Red: Serious adverse events leading to >2 patients discontinuing the trial
Measured: 4 months
Secondary outcomes (11)
WOSI
Western Ontario Stability Index questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems.
This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score.
Overall, the questionnaire is scored as a percentage of the maximum score of 2100 points.
There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300).
Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score.
Measured: 4 months
Pain level
Assessment of shoulder pain will be measured by the Numerical Rating scale of pain (NRS) with numbers from 0 - 10 ("no pain" to "worst pain imaginable"). The pain level will be measured at baseline as the intensity of pain right now, and at 16 weeks follow-up, and in addition, the worst, least and average pain level for the latest week will be measured one time weekly.
Measured: 4 months
Checklist Individual Strength (CIS)
Assessment of fatigue by the Checklist Individual Strength (CIS), subscale fatigue will be performed at baseline and at 16-week follow up to report the change in level of fatigue. CIS Subscale fatigue consists of 8 items each scored on a 7-point Likert scale (scores ranging from 8 to 56) with high scores indicating high levels of fatigue
Measured: 4 months
COOP/WONCA
To assess the change in functional health status from baseline to 16 weeks follow-up the COOP/WONCA questionnaire will be used. The questionnaire is a generic health status questionnaire for General Practice patients. The questionnaire consists of six single-item measures; physical fitness, feelings (mental well-being), daily activities, social activities, besides change in health and overall health. The categories chosen are scored from one (good functional status) to five (poor functional status)
Measured: 4 months
Tampa Scale of Kinesiophobia (TSK-11)
Tampa scale of Kinesiophobia is used to measure impression of change in fear of movement from baseline to 16 weeks follow-up. It consists of an 11-item scale where each question is scored on a 4 point Likert scale, with 1 indicating, "strongly disagree" and 4 indicating, "strongly agree". The total scores range from 11-44, with higher scores representing increased fear of movement.
Measured: 4 months
Global Perceived Effect (GPE)
To measure the patients self-rated impression of recovery at follow-up the GPE will be used. GPE measures self-rated impression of recovery since baseline assessment on a 7-point scale (1= worst ever; 2= much worse; 3= a little worse; 4= not changed; 5= a little improved; 6= much improved; and 7= best ever)
Measured: 4 months
EQ-5D-5L Health status questionnaire
The EQ-5D-5L measures change in health related quality of life. It comprises five dimensions (mobility, Self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension is rated using a five-level ordinal scale from no problems to extreme problems. It results in a preference based index that range from states worse than death (<0), to 1 (full health), anchoring dead at 0. A score of one indicates that the participants perceived their health at the best possible state and a score below null that the participants perceived their health worse than death. In addition, the EQ-5D includes an EQ-VAS where own health "today" is rated on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: 4 months
IPAQ short version
Physical Activity Questionnaire. To measure the weekly physical activity level the short version of the IPAQ will be used. The IPAQ collects information on time spent on physical activity (PA) at moderate and vigorous intensity and walking in 4 domains: work, transportation, housework/gardening, and leisure time. Questions are supplied with examples of common activities. In all domains, participants are asked to indicate the amount of time spent on PA in the past 7 days in relation to frequency (days) and duration (hours or minutes) of the activity.
Measured: 4 months
Isometric shoulder strength
Maximum isometric voluntary contraction (MVC) in shoulder scaption, internal rotation and external rotation using a hand-held dynamometer.
Measured: 4 months
Active and passive shoulder range of motion
Internal rotation and external rotation with shoulder in 90 degrees of abduction is measured using a HALO digital goniometer.
Measured: 4 months
Shoulder proprioception
Shoulder proprioception is measured in shoulder flexion angles using af HALO digital goniometer.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start4 May 2018
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypermobility Syndrome ShoulderStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group only.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Municipality, Region of Southern Denmark, The Danish Rheumatism Association
- Responsible party
- Principal investigator, Behnam Liaghat, University of Southern Denmark
- Investigators
- Behnam Liaghat, MSc, Principal investigator, University of Southern DenmarkBirgit Juul-Kristensen, PhD, Study director, University of Southern DenmarkSøren T Skou, PhD, Study chair, University of Southern Denmark, Næstved-Slagelse-Ringsted HospitalsKaren Søgaard, PhD, Study chair, University of Southern DenmarkJens Søndergaard, MD, PhD, Study chair, University of Southern DenmarkUffe Jørgensen, MD, Study chair, Odense University Hospital, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547570
- Sponsor's protocol ID
- S-20170066
- Status last verified
- Apr 2021
- First submitted
- 3 May 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liaghat B, Skou ST, Jorgensen U, Sondergaard J, Sogaard K, Juul-Kristensen B. Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study. Pilot Feasibility Stud. 2020 Jul 10;6:97. doi: 10.1186/s40814-020-00632-y. eCollection 2020.
PubMed 32670599
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Heavy Shoulder Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03547570
- Acronym / sponsor ID
- S-20170066
- Keywords
- Joint instability, Hypermobility, Shoulder, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Esbjerg Municipality, Region of Southern Denmark, The Danish Rheumatism Association
- Study start
- 4 May 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms.
Detailed description
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms before safely performing a definitive RCT-study in a large cohort. The objectives are to address whether PHSRT is feasible regarding i) patient recruitment and retention, ii) adherence to exercise protocol and its progression levels, iii) completion of objective outcome measures, and iv) registering potential flare up in shoulder symptoms.
Study progression criteria are based on a traffic light system of green (go), amber (amend) and red (stop). Results of these progression criteria will be evaluated by the investigator group, who will recommend amendments that need to be made before proceeding with the definitive RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group only.
| Arm | Type | Receives |
|---|---|---|
| Heavy shoulder resistance training | Experimental | Other: Progressive heavy shoulder resistance trainingProgressive heavy shoulder resistance training performed twice a week at the physiotherapy clinic under supervision, while once weekly training at home will be recommended. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 18 - 65
- Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men [21, 22] or historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items). In patients with acquired joint limitations (past surgery, wheelchair, amputations) affecting the Beighton score calculation, the assessment of GJH only included a positive 5 part-questionnaire.
- Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either musculoskeletal pain in minimum one shoulder for at least three months or recurrent joint dislocations or joint instability without a reported history of trauma defined as: a) minimum three atraumatic dislocations in same shoulder or minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or b) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.
Key exclusion criteria (6 listed)
- Clinically suspected referred pain from the cervical spine
- Systemic rheumatic diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes)
- Neurological diseases
- Pregnancy or childbirth within the latest year
- Shoulder surgery within the past year
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 |
|---|---|---|
| Progressive heavy shoulder resistance trainingThe training programme includes five exercises identified in literature to target scapular and rotator cuff muscles. | Other | Heavy shoulder resistance training |
Primary outcome
Patient recruitment
Time frame: 4 months
Green: Inclusion rate of one patient per general practitioner or physiotherapist every month (approximately n=6-8/month). Amber: If the recruitment rate falls behind, screening logs and reasons for exclusion will be explored after the first month in order to adjust eligibility criteria (n<6 after first month) Red: No recruitment after two months
Completion of the outcome measures
Time frame: Baseline measures
Green: 120 minutes for completing all objective outcome measures and at least 67% of patients answering that it was an acceptable duration Amber: Between 121-150 minutes or between 50-66% of patients answering that it was an acceptable duration Red: >150 minutes or <50% of patients answering that it was an acceptable duration
Patient retention
Time frame: 4 months
Green: 10 or more patients show up at 16-weeks follow up Amber: 6-9 patients show up at 16-weeks follow up Red: Less than 6 patients show up at 16-weeks follow up
Adherence to training intervention
Time frame: 4 months
Green: At least 75% of patients adhering to at least 75% of training sessions Amber: 50-75% of patients adhering to 50-75% of training sessions Red: <50% of patients adhering to <50% of training sessions
Adverse events
Time frame: 4 months
Green: No or minor adverse events with no patients discontinuing the trial Amber: Minor or serious adverse events leading to 2 or less patients discontinuing the trial Red: Serious adverse events leading to >2 patients discontinuing the trial
11 secondary outcomes
WOSI
Time frame: 4 months
Pain level
Time frame: 4 months
Checklist Individual Strength (CIS)
Time frame: 4 months
COOP/WONCA
Time frame: 4 months
Tampa Scale of Kinesiophobia (TSK-11)
Time frame: 4 months
Global Perceived Effect (GPE)
Time frame: 4 months
EQ-5D-5L Health status questionnaire
Time frame: 4 months
IPAQ short version
Time frame: 4 months
Isometric shoulder strength
Time frame: 4 months
Active and passive shoulder range of motion
Time frame: 4 months
Shoulder proprioception
Time frame: 4 months
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 30 Apr 2021.
- Results publication: PubMed 32670599Liaghat B, Skou ST, Jorgensen U, Sondergaard J, Sogaard K, Juul-Kristensen B. Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study. Pilot Feasibility Stud. 2020 Jul 10;6:97. doi: 10.1186/s40814-020-00632-y. eCollection 2020.
- Manuscript open accessLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Behnam Liaghat, MSc principal investigator
University of Southern Denmark
Birgit Juul-Kristensen, PhD study director
University of Southern Denmark
Søren T Skou, PhD study chair
University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive heavy shoulder resistance training in people with Hypermobility Syndrome Shoulder and Shoulder Pain Chronic, run by University of Southern Denmark at 3 sites in Denmark.
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 3 inclusion and 6 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Patient recruitment (time frame: 4 months). The study lists 5 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 NCT03547570, which also lists 1 linked publication.
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 30 Apr 2021.