Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

About this trial

Last updated a month ago

Study ID

Pilate Exercises for DED2025

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

40 to 60 Years

Male

Trial Timing

Started 5 months ago

What is this trial about?

Erectile dysfunction (ED) has a prevalence of 52.5% in diabetic male patients, as described in a meta-analysis of 145 studies, including 88,577 men with type 1 and type 2 diabetes. In men, ED can cause sexual dissatisfaction and distress, unsatisfactory relationships, and marital tension

What are the participation requirements?

Inclusion Criteria

1. Men aged 40-60 years.

2. Diagnosed diabetes mellitus (type 2) ≥ 1 year.

3. Clinical diagnosis of erectile dysfunction for ≥ 6 months, confirmed by IIEF5 score.

4. Stable antidiabetic medications for ≥ 3 months prior to randomization.

5. HbA1c between 6.5% and 10.0%.

6. Sexually active or attempting sexual activity at least occasionally (at least once monthly) and willing to attempt intercourse during study.

7. Able and willing to participate in the exercise program (physically capable and available for scheduled sessions) and provide written informed consent.

Exclusion Criteria

1. Severe cardiovascular disease within past 6 months (e.g., recent myocardial infarction, unstable angina, decompensated heart failure, uncontrolled arrhythmia) that contraindicates exercise.

2. Uncontrolled hypertension (e.g., systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg) despite treatment.

3. Severe peripheral vascular disease or other conditions preventing safe exercise (severe claudication, severe orthopedic limitations).

4. History of pelvic surgery or pelvic radiation within the last 12 months that could acutely affect erectile function.

5. Primary neurogenic causes of ED unrelated to diabetes (spinal cord injury, multiple sclerosis).

6. Major psychiatric illness or severe cognitive impairment interfering with consent/compliance .

7. Current substance abuse or heavy alcohol use that could affect sexual function or compliance.

8. Severe hypogonadism requiring imminent testosterone therapy (total testosterone < 8 nmol/L with symptoms).

9. Active genitourinary infection or untreated severe sexual dysfunction disorders other than ED.

10. Use of medications known to cause ED that cannot be discontinued or stabilized.

11. Current participation in structured pelvic floor or sexual-function exercise program similar to the intervention.

12. Recent (within 4 weeks) or planned changes in PDE5i therapy.

13. Any medical condition making participation unsafe or likely to confound outcomes per investigator judgment.