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

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

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Other: Moderate Physical Activity + Conventional Physical Therapy; Other: Conventional Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 46600
      • Riphah Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (Moderate Physical Activity + Conventional Physical Therapy); Conventional 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	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
Active Comparator: Control (Conventional Physical Therapy); Conventional 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Shoulder Pain	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	From baseline to 3rd week and 6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH Questionnaire	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale	6th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Waqar Ahmed Awan, PHD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: RCRS/SPT/01240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No