Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy

NCT07784543 | Not Yet Recruiting

• 1 other identifier: PamukkaleU.ftr-AATIGAN-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by elevated blood glucose levels over a prolonged period. If left untreated, it can lead to serious and long-term vascular and neurological complications. It is also a major cause of morbidity due to specific microvascular complications (retinopathy, nephropathy, and neuropathy), macrovascular complications (ischemic heart disease, stroke, and peripheral vascular disease), and reduced quality of life. There are studies in the literature investigating conventional and shoulder-specific treatments for various shoulder pathologies in patients with type 2 diabetes mellitus (T2DM) . However, very few studies have investigated the effectiveness of aerobic exercise. The investigators identified only one study that evaluated the effects of aerobic exercise on pain and range of motion in patients with T2DM and adhesive capsulitis. In the present study, the investigators aim to demonstrate that aerobic exercise results in statistically significant improvements in shoulder pain, functional disability, and the structural characteristics of the supraspinatus tendon, as assessed by ultrasonography and elastography, in participants with T2DM and supraspinatus tendinopathy. The investigators believe that the findings of this study will provide scientific evidence to support the development of more effective and comprehensive rehabilitation protocols for participants with diabetes and shoulder pain.

Conditions

Supraspinatus Tendinopathy; Type 2 Diabetes Mellitus (T2DM)

Keywords

Shoulder Pain; Aerobic Exercise; Supraspinatus Tendinopathy; Type 2 Diabetes Mellitus; Ultrasonography; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain Assessed by Visual Analog Scale (VAS)

  Shoulder pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

  Baseline (Week 0) and post-treatment (Week 6)

Secondary Outcomes (4)

• Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index (SPADI)

  Baseline (Week 0) and post-treatment (Week 6)

• Supraspinatus Tendon Thickness Assessed by Ultrasonography

  Baseline (Week 0) and post-treatment (Week 6)

• Supraspinatus Tendon Stiffness Assessed by Strain Elastography

  Baseline (Week 0) and post-treatment (Week 6)

• Central Sensitization Inventory (CSI)

  Baseline (Week 0) and post-treatment (Week 6)

Study Arms (2)

Conventional Rehabilitation

ACTIVE COMPARATOR

Conventional physical therapy will be administered 5 sessions per week for a total of 30 sessions. The treatment program will include 20 minutes of heat therapy, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of therapeutic ultrasound at an intensity of 1.5 W/cm², and shoulder-specific exercises performed under the supervision of a physiotherapist. The supervised exercise program will include pendulum exercises, range-of-motion exercises, posterior capsule and pectoral stretching, scapular stabilization exercises, and strengthening exercises for the rotator cuff muscles .

Behavioral: Conventional Shoulder Rehabilitation

Conventional Physical Therapy + Aerobic Exercise

EXPERIMENTAL

In addition to the conventional shoulder rehabilitation protocol, participants will receive an aerobic exercise program. The aerobic exercise program will be implemented in accordance with the current physical activity and exercise recommendations of the American Diabetes Association. Participants will perform moderate-intensity treadmill walking 5 days per week for 30 minutes per session, at an intensity corresponding to 50-60% of heart rate reserve. Each session will consist of a 5-minute warm-up, 20 minutes of aerobic exercise on the treadmill, and a 5-minute cool-down. After the fourth week, the exercise duration will be increased to 40 minutes per session, consisting of a 5-minute warm-up, 30 minutes of aerobic exercise on the treadmill, and a 5-minute cool-down. All exercise sessions will be performed under the supervision of a physiotherapist and in accordance with appropriate safety protocols . The treatment program will be administered for a total of 6 weeks.

Behavioral: Aerobic Exercise

Interventions

Conventional Shoulder Rehabilitation BEHAVIORAL

Conventional physical therapy will be administered 5 days per week for 6 weeks (30 sessions). The program will include heat therapy, TENS, therapeutic ultrasound, and supervised shoulder-specific exercises, including range-of-motion, stretching, scapular stabilization, and rotator cuff strengthening exercises.

Conventional Rehabilitation

Aerobic Exercise BEHAVIORAL

In addition to conventional shoulder rehabilitation, participants will perform moderate-intensity treadmill aerobic exercise (50-60% of heart rate reserve) 5 days per week for 6 weeks. Sessions will initially last 30 minutes (5-minute warm-up, 20-minute exercise, and 5-minute cool-down) and will increase to 40 minutes after Week 4. All sessions will be supervised by a physiotherapist and conducted according to appropriate safety protocols.

Conventional Physical Therapy + Aerobic Exercise

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-70 years.
• Having a diagnosis of type 2 diabetes mellitus (T2DM) for more than 1 year.
• Having unilateral or bilateral shoulder pain for at least 3 months and a diagnosis of supraspinatus tendinopathy confirmed by magnetic resonance imaging (MRI).
• Having a pain intensity score of ≥3 on the Visual Analog Scale (VAS).
• No participation in regular exercise during the past 6 months

You may not qualify if:

• Having received shoulder rehabilitation within the past 6 months.
• Having a full-thickness tear of the supraspinatus tendon.
• Having a history of fracture, surgery, or injection in the upper extremity within the past 6 months.
• Having a diagnosis of a neuromuscular disease, rheumatic disease, or severe cardiovascular disease.
• Having advanced diabetic complications.
• Having any condition that contraindicates or prevents participation in aerobic exercise.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University, Denizli

Denizli, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Shoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alev ATIGAN, Assistant Professor

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Melike LALE, MD

CONTACT

+905357822420; melikesalar1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)