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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Moderate Physical Activity + Conventional Physical Therapy
Conventional Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Uncontrolled Type 2 diabetes patients
  • Age between 40 to 65 years old
  • Male female both

Exclusion Criteria:

  1. Lower limb musculoskeletal injuries
  2. Surgery or trauma in past 6 months
  3. Diabetic foot ulcer patients
  4. Acute or chronic heart disease
  5. Renal insufficiency or failiure
  6. Gastrointestinal disease
  7. Mobility disorder
  8. Rheumatologic disorder

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental (Moderate Physical Activity + Conventional Physical Therapy)

Control (Conventional Physical Therapy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
Shoulder Pain
Shoulder pain will be assessed with Visual Analogue scale (VAS) is a reliable and valid tool CI = 0.96 to 0.98.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
August 24, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04925128
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups with randomization. Assignment; treadmill walking
Masking
Participant
Masking Description
single participant according to study
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental (Moderate Physical Activity + Conventional Physical Therapy)
Arm Type
Experimental
Arm Description
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
Arm Title
Control (Conventional Physical Therapy)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Moderate Physical Activity + Conventional Physical Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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 Outcome Measure Information:
Title
Average Blood Glucose Level
Description
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)
Time Frame
From baseline to 6th week
Title
Shoulder Pain
Description
Shoulder pain will be assessed with Visual Analogue scale (VAS) is a reliable and valid tool CI = 0.96 to 0.98.
Time Frame
From baseline to 3rd week and 6th week
Title
Shoulder ROMs
Description
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.
Time Frame
From baseline to 3rd week and 6th week
Title
Shoulder Functionality
Description
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
Time Frame
From baseline to 3rd week and 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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