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

Not Applicable
Completed
Conditions
Adhesive Capsulitis of Shoulder
Interventions
Other: Conventional Physical Therapy
Other: Moderate Physical Activity + Conventional Physical Therapy
Registration Number
NCT04925128
Lead Sponsor
Riphah International University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
Inclusion Criteria

Not provided

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control (Conventional Physical Therapy)Conventional Physical TherapyConventional Physical Therapy group recieved Hot pack and TENS for 10 minutes at the affected shoulder. Passive shoulder mobilizations were performed initially at pain free range in anterior, posterior, and inferior direction (10 reps x 1 set). Shoulder rolls, pendulum stretch, cross body arm stretch and towel stretch (10 reps x 1 set) were actively performed by the patient with-in limits of pain
Experimental (Moderate Physical Activity + Conventional Physical Therapy)Moderate Physical Activity + Conventional Physical TherapyConventional Physical Therapy group recieved Hot pack and TENS for 10 minutes at the affected shoulder. Passive shoulder mobilizations were performed initially at pain free range in anterior, posterior, and inferior direction (10 reps x 1 set). Shoulder rolls, pendulum stretch, cross body arm stretch and towel stretch (10 reps x 1 set) were actively performed by the patient with-in limits of pain Moderate physical activity on treadmill, brisk walk was performed 5 days a week for 30 minutes at 4 mph speed (3-6 METs) with warm up for a 5 minutes at low speed and then at the end speed was also decreased for a 5 minutes
Primary Outcome Measures
NameTimeMethod
Shoulder PainFrom 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 ROMsFrom 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 FunctionalityFrom 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 LevelFrom 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Riphah Rehabilitation Center

🇵🇰

Islamabad, Punjab, Pakistan

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