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

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925128
• Other study ID #: RCRS/SPT/01240
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• Moderate Physical Activity + Conventional Physical Therapy
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
• Conventional Physical Therapy
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

Locations

Country	Name	City	State
Pakistan	Riphah Rehabilitation Center	Islamabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Blood Glucose Level	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)	From baseline to 6th week
Primary	Shoulder Pain	Shoulder pain will be assessed with numeric pain rating scale (NPRS), a reliable (Cronbach's a=0.94) and valid tool (CI = 0.96 to 0.98) for assessing pain	From baseline to 3rd week and 6th week
Primary	Shoulder ROMs	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.	From baseline to 3rd week and 6th week
Primary	Shoulder Functionality	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	From baseline to 3rd week and 6th week