Clinical trial NCT03547570: Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Official title: Progressive Heavy Shoulder Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobility Syndrome Shoulder
Shoulder Pain Chronic
Keywords: Joint instability
Hypermobility
Shoulder
Strength training
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Esbjerg Municipality
name: Region of Southern Denmark
name: The Danish Rheumatism Association
First posted: 2018-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group only.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient recruitment
timeFrame: 4 months
measure: Completion of the outcome measures
timeFrame: Baseline measures
measure: Patient retention
timeFrame: 4 months
measure: Adherence to training intervention
timeFrame: 4 months
measure: Adverse events
timeFrame: 4 months
Secondary outcomes:
measure: WOSI
timeFrame: 4 months
measure: Pain level
timeFrame: 4 months
measure: Checklist Individual Strength (CIS)
timeFrame: 4 months
measure: COOP/WONCA
timeFrame: 4 months
measure: Tampa Scale of Kinesiophobia (TSK-11)
timeFrame: 4 months
measure: Global Perceived Effect (GPE)
timeFrame: 4 months
measure: EQ-5D-5L Health status questionnaire
timeFrame: 4 months
measure: IPAQ short version
timeFrame: 4 months
measure: Isometric shoulder strength
timeFrame: 4 months
measure: Active and passive shoulder range of motion
timeFrame: 4 months
measure: Shoulder proprioception
timeFrame: 4 months
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: GP´s and physiotherapists
state: Egion Of Southern Denmark
city: Esbjerg
country: Denmark
facility: GP´s and physiotherapists
state: Region Of Southern Denmark
city: Odense
country: Denmark
facility: GP´s and physiotherapists
state: Region Of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Behnam Liaghat, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Birgit Juul-Kristensen, PhD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
name: Søren T Skou, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Karen Søgaard, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Jens Søndergaard, MD, PhD
role: STUDY_CHAIR
affiliation: Odense University Hospital, University of Southern Denmark
name: Uffe Jørgensen, MD
role: STUDY_CHAIR
References:
citation: 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.