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Clinical Trials/NCT04925128
NCT04925128
Completed
Not Applicable

Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial

Riphah International University1 site in 1 country44 target enrollmentJanuary 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adhesive Capsulitis of Shoulder
Sponsor
Riphah International University
Enrollment
44
Locations
1
Primary Endpoint
Shoulder Pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study is designed to determine the effects of moderate physical activity on adhesive capsulitis in patients with uncontrolled diabetes mellitus.

Detailed Description

This study aims to investigate the effect of additional Physical activity programmes in patients with Diabetic Frozen Shoulder (DFS). Physical activity can help people with diabetes achieve a variety of goals, including increased cardiorespiratory fitness, increased vigour, improved glycemic control, decreased insulin resistance, improved lipid profile, blood pressure (BP) reduction and maintenance of weight loss Frozen shoulder syndrome, also known as adhesive capsulitis, is a clinical entity that refers to a stiff and painful shoulder causing major functional impairment. It affects women more than men, and is mostly associated with diabetes mellitus as a systemic condition. . Frozen shoulder may be either primary idiopathic or secondary to a systemic disease, such as diabetes mellitus. The adoption and maintenance of physical activity are critical for blood glucose management and overall health in individuals with diabetes. In this Position Statement, we provide a clinically oriented review and evidence based recommendations regarding physical activity and exercise in people with type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
January 20, 2022
End Date
December 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • The patients with history of shoulder dislocation
  • Lower limb injury,
  • Diabetic foot ulcer,
  • Diabetic neuropathy,
  • Acute or chronic heart disease,
  • Rheumatologic disorder
  • Mobility disorder and post-surgical or trauma related patients will be excluded during the screening.

Outcomes

Primary Outcomes

Shoulder Pain

Time Frame: From baseline to 3rd week and 6th week

Shoulder pain will be assessed with numeric pain rating scale (NPRS), a reliable (Cronbach's α=0.94) and valid tool (CI = 0.96 to 0.98) for assessing pain

Shoulder ROMs

Time Frame: From baseline to 3rd week and 6th week

Shoulder abduction, external rotation and internal rotation will be assessed with goiniometer for the degree and quality of this movement. The reliability of goiniometer for shoulder ROMs is ICC=0.94 and validity ICC=0.94.

Shoulder Functionality

Time Frame: From baseline to 3rd week and 6th week

Disability of Arm, Shoulder, and Hand (DASH) questionnaire will be used to assess shoulder functionality which is considered a reliable and valid tool for upper limb function. It has been used for shoulder assessment in patients with AC. Validity and Reliability of this scale is (ICC=0.95) and (ICC=0.92) respectively

Average Blood Glucose Level

Time Frame: From baseline to 6th week

The average blood glucose level for past two to three months will be measured throgh the HbA1c test, also known as the haemoglobinA1c . The normal range for the hemoglobin A1c level is between 4% and 5.6%. Between 5.7% and 6.4%indicates pre-diabetes. 6.5% or higher indicates diabetes. Validity (r=0.96 and 0.99) and reliability (r=0.95 and 0.97)

Study Sites (1)

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