Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2014-09-30
2016-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ADA guideline Instructed
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
ADA Guideline Instructed
The ADA guideline instructions are to include: blood sugar control (goal is A1c \< 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is \<130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.
Optimized Shoulder Movement Program
The experimental intervention is the Optimized Shoulder Movement Program. Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation, and active shoulder motion based on the participant's baseline "activity count" .
Optimized Shoulder Movement Program
A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured "activity count" at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity.
Interventions
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Optimized Shoulder Movement Program
A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured "activity count" at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity.
ADA Guideline Instructed
The ADA guideline instructions are to include: blood sugar control (goal is A1c \< 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is \<130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diagnosed rotator cuff tear
* recent (6 months) upper extremity injury and/or fractures
* surgery in the upper extremity or thorax
* cervical radiculopathy
* thoracic outlet syndrome
* stroke with residual upper extremity involvement
* severe skin allergies in area to be tested
* rheumatic conditions
* known connective tissue diseases
* carpal tunnel syndrome
* use of a cane
* individuals who engage in heavy upper extremity/ overhead use (ie, painters, tennis players) because they likely have a different mechanism of injury than those with low shoulder activity.
40 Years
70 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Michael J Mueller, PT, PHD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Mueller MJ, Sorensen CJ, McGill JB, Clark BR, Lang CE, Chen L, Bohnert KL, Hastings MK. Effect of a Shoulder Movement Intervention on Joint Mobility, Pain, and Disability in People With Diabetes: A Randomized Controlled Trial. Phys Ther. 2018 Sep 1;98(9):745-753. doi: 10.1093/ptj/pzy070.
Other Identifiers
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US NIH Grant R21 DK100793-01A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2014_DM_LJM
Identifier Type: -
Identifier Source: org_study_id