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Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547570
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Esbjerg Municipality
Region of Southern Denmark
The Danish Rheumatism Association
Information provided by (Responsible Party):
Behnam Liaghat, University of Southern Denmark

Brief 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 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.


Condition or disease Intervention/treatment Phase
Hypermobility Syndrome Shoulder Shoulder Pain Chronic Other: Progressive heavy shoulder resistance training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Intervention group only.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Progressive Heavy Shoulder Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018

Arm Intervention/treatment
Experimental: Heavy shoulder resistance training
Progressive heavy shoulder resistance training performed twice a week at the physiotherapy clinic under supervision, while once weekly training at home will be recommended.
Other: Progressive heavy shoulder resistance training
The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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


  5. 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



Secondary Outcome Measures :
  1. WOSI [ Time Frame: 4 months ]

    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.


  2. Pain level [ Time Frame: 4 months ]
    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.

  3. Checklist Individual Strength (CIS) [ Time Frame: 4 months ]
    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

  4. COOP/WONCA [ Time Frame: 4 months ]
    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)

  5. Tampa Scale of Kinesiophobia (TSK-11) [ Time Frame: 4 months ]
    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.

  6. Global Perceived Effect (GPE) [ Time Frame: 4 months ]
    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)

  7. EQ-5D-5L Health status questionnaire [ Time Frame: 4 months ]
    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).

  8. IPAQ short version [ Time Frame: 4 months ]
    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.

  9. Isometric shoulder strength [ Time Frame: 4 months ]
    Maximum isometric voluntary contraction (MVC) in shoulder scaption, internal rotation and external rotation using a hand-held dynamometer.

  10. Active and passive shoulder range of motion [ Time Frame: 4 months ]
    Internal rotation and external rotation with shoulder in 90 degrees of abduction is measured using a HALO digital goniometer.

  11. Shoulder proprioception [ Time Frame: 4 months ]
    Shoulder proprioception is measured in shoulder flexion angles using af HALO digital goniometer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547570


Locations
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Denmark
GP´s and physiotherapists
Middelfart, Egion Of Southern Denmark, Denmark
GP´s and physiotherapists
Esbjerg, Region Of Southern Denmark, Denmark
GP´s and physiotherapists
Odense, Region Of Southern Denmark, Denmark
Sponsors and Collaborators
University of Southern Denmark
Esbjerg Municipality
Region of Southern Denmark
The Danish Rheumatism Association
Investigators
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Principal Investigator: Behnam Liaghat, MSc University of Southern Denmark
Study Director: Birgit Juul-Kristensen, PhD University of Southern Denmark
Study Chair: Søren T Skou, PhD University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
Study Chair: Karen Søgaard, PhD University of Southern Denmark
Study Chair: Jens Søndergaard, MD, PhD University of Southern Denmark
Study Chair: Uffe Jørgensen, MD Odense University Hospital, University of Southern Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Behnam Liaghat, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03547570    
Other Study ID Numbers: S-20170066
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Behnam Liaghat, University of Southern Denmark:
Joint instability
Hypermobility
Shoulder
Strength training
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations