Clinical trial NCT04925128: Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial
Official title: Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with randomization. Assignment; treadmill walking
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria :

1. The male and female physically active with uncontrolled diabetic (\>6.5% HBA1c) patients those taking medicine to controlled it from more than 3 years.
2. The age of the participants will be between 40 to 65-years,
3. having stage 1 or 2 adhesive capsulitis (AC) with a capsular pattern included in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Average Blood Glucose Level
timeFrame: From baseline to 6th week
measure: Shoulder Pain
timeFrame: From baseline to 3rd week and 6th week
measure: Shoulder ROMs
timeFrame: From baseline to 3rd week and 6th week
measure: Shoulder Functionality
timeFrame: From baseline to 3rd week and 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References: