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Completed

NCT Number: NCT04925128

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.

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Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehabilitation Center

Islamabad, Punjab Province, 46600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Moderate Physical Activity + Conventional Physical Therapy

Other

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

Other

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

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2021
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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