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

NCT04925128 | Completed DMC

• 1 other identifier: RCRS/SPT/01240
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (4)

• 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 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

• 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

Study Arms (2)

Experimental (Moderate Physical Activity + Conventional Physical Therapy)

EXPERIMENTAL

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

Control (Conventional Physical Therapy)

ACTIVE COMPARATOR

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

Interventions

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

Experimental (Moderate Physical Activity + Conventional Physical Therapy)

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

Control (Conventional Physical Therapy)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Center

Islamabad, Punjab Province, 46600, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Waqar Ahmed Awan, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single participant according to study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups with randomization. Assignment; treadmill walking

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: June 14, 2021
• Study Start: January 20, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2022
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)