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

NCT03547570 | Completed DMC

• 1 other identifier: S-20170066
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypermobility Syndrome Shoulder; Shoulder Pain Chronic

Keywords

Joint instability; Hypermobility; Shoulder; Strength training

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  4 months

Secondary Outcomes (11)

• WOSI

  4 months

• Pain level

  4 months

• Checklist Individual Strength (CIS)

  4 months

• COOP/WONCA

  4 months

• Tampa Scale of Kinesiophobia (TSK-11)

  4 months

Study Arms (1)

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.

Other: Progressive heavy shoulder resistance training

Interventions

Progressive heavy shoulder resistance training OTHER

The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.

Heavy shoulder resistance training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Esbjerg Municipality: collaborator
• Region of Southern Denmark: collaborator
• The Danish Rheumatism Association: collaborator

Study Sites (3)

GP´s and physiotherapists

Middelfart, Egion of Southern Denmark, Denmark

Location

GP´s and physiotherapists

Esbjerg, Region Syddanmark, Denmark

Location

GP´s and physiotherapists

Odense, Region Syddanmark, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32670599 RESULT

Related Links

• Manuscript open access

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Behnam Liaghat, MSc

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Birgit Juul-Kristensen, PhD

  University of Southern Denmark

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group only.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 6, 2018
• Study Start: May 4, 2018
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)