Back to resultsResistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Primary Purpose
Hypermobility Syndrome Shoulder, Shoulder Pain Chronic
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Progressive heavy shoulder resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Hypermobility Syndrome Shoulder focused on measuring Joint instability, Hypermobility, Shoulder, Strength training
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.
Sites / Locations
- GP´s and physiotherapists
- GP´s and physiotherapists
- GP´s and physiotherapists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heavy shoulder resistance training
Arm Description
Progressive heavy shoulder resistance training performed twice a week at the physiotherapy clinic under supervision, while once weekly training at home will be recommended.
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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.
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.
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
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)
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.
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)
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).
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.
Isometric shoulder strength
Maximum isometric voluntary contraction (MVC) in shoulder scaption, internal rotation and external rotation using a hand-held dynamometer.
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.
Shoulder proprioception
Shoulder proprioception is measured in shoulder flexion angles using af HALO digital goniometer.
Full Information
NCT ID
NCT03547570
First Posted
May 3, 2018
Last Updated
April 27, 2021
Sponsor
University of Southern Denmark
Collaborators
Esbjerg Municipality, Region of Southern Denmark, The Danish Rheumatism Association
1. Study Identification
Unique Protocol Identification Number
NCT03547570
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Esbjerg Municipality, Region of Southern Denmark, The Danish Rheumatism Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility Syndrome Shoulder, Shoulder Pain Chronic
Keywords
Joint instability, Hypermobility, Shoulder, Strength training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention group only.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heavy shoulder resistance training
Arm Type
Experimental
Arm Description
Progressive heavy shoulder resistance training performed twice a week at the physiotherapy clinic under supervision, while once weekly training at home will be recommended.
Intervention Type
Other
Intervention Name(s)
Progressive heavy shoulder resistance training
Intervention Description
The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.
Primary Outcome Measure Information:
Title
Patient recruitment
Description
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
Time Frame
4 months
Title
Completion of the outcome measures
Description
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
Time Frame
Baseline measures
Title
Patient retention
Description
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
Time Frame
4 months
Title
Adherence to training intervention
Description
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
Time Frame
4 months
Title
Adverse events
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
WOSI
Description
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.
Time Frame
4 months
Title
Pain level
Description
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.
Time Frame
4 months
Title
Checklist Individual Strength (CIS)
Description
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
Time Frame
4 months
Title
COOP/WONCA
Description
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)
Time Frame
4 months
Title
Tampa Scale of Kinesiophobia (TSK-11)
Description
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.
Time Frame
4 months
Title
Global Perceived Effect (GPE)
Description
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)
Time Frame
4 months
Title
EQ-5D-5L Health status questionnaire
Description
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).
Time Frame
4 months
Title
IPAQ short version
Description
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.
Time Frame
4 months
Title
Isometric shoulder strength
Description
Maximum isometric voluntary contraction (MVC) in shoulder scaption, internal rotation and external rotation using a hand-held dynamometer.
Time Frame
4 months
Title
Active and passive shoulder range of motion
Description
Internal rotation and external rotation with shoulder in 90 degrees of abduction is measured using a HALO digital goniometer.
Time Frame
4 months
Title
Shoulder proprioception
Description
Shoulder proprioception is measured in shoulder flexion angles using af HALO digital goniometer.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behnam Liaghat, MSc
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Søren T Skou, PhD
Organizational Affiliation
University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen Søgaard, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens Søndergaard, MD, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Uffe Jørgensen, MD
Organizational Affiliation
Odense University Hospital, University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
GP´s and physiotherapists
City
Middelfart
State/Province
Egion Of Southern Denmark
Country
Denmark
Facility Name
GP´s and physiotherapists
City
Esbjerg
State/Province
Region Of Southern Denmark
Country
Denmark
Facility Name
GP´s and physiotherapists
City
Odense
State/Province
Region Of Southern Denmark
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32670599
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.
Results Reference
result
Links:
URL
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00632-y
Description
Manuscript open access
Learn more about this trial
Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
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