Effect of Aquatic Exercise and Traditional Physical Therapy on Gout in Hypertensive Menopausal Women With Hyperuricemia

Not Applicable

• Conditions: Gout
• Interventions: Other: traditional physical therapy + anti-hyperuricemia medication; Other: the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication

• Registration Number: NCT05454423
• Lead Sponsor: Merit University

Brief Summary

Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.

Detailed Description

Menopause is defined as a point in time 12 months after a woman's last period. During the menopausal transition, changes in estrogen and progesterone levels affect not only vasomotor symptoms, sexual dysfunction, osteoporosis, and cardiovascular disease (CVD), but also uric acid level1. An association between menopausal status and hyperuricemia has been previously examined. A study using the Third National Health and Nutrition Examination Survey showed a positive and independent association of menopause with hyperuricemia and gout. It's believed that estrogen has a protective effect that is removed at menopause, thus accounting for the rise in gout in women who are postmenopausal2.

Hyperuricemia is a common biochemical abnormality resulting from excessive uric acid production or impaired clearance of uric acid. Although its pathophysiology is not fully understood, genetic, comorbid disease-related, and environmental (drug, diet, and toxic exposure-induced) factors are involved in hyperuricemia3.

Gout is a multifactorial disease caused by hyperuricemia and monosodium urate crystals deposition. Pain typically comes on rapidly, reaching maximal intensity in less than 12 hours. The joint at the base of the big toe is affected in about half of cases4.

Study Timeline

• Study First Submitted: 2022-06-29
• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted QC: 2022-07-07
• Last Update Submitted: 2022-07-07
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 100 patients with gout

  • Age between 45 -65 years
  • Cooperative patient.
  • A physician referred all patients with the diagnosis of gout

Exclusion Criteria

• history of kidney disease such as chronic kidney disease, Cancer patients. Smokers Patients with chronic heart disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional physical therapy + anti-hyperuricemia medication	traditional physical therapy + anti-hyperuricemia medication	consisted of 50 Patients received traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose.
aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication	the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication	consisted of 50 Patients received aquatic exercise and Traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose.

Primary Outcome Measures

Name	Time	Method
The Borg Rating of Perceived Exertion (RPE) scale	2 week before and 2 week after	will be used to measure the level of exertional effort for both groups A \& B before and after treatment
Serum uric acid level before and after treatment for both groups (A and B): Table 2: Mean values for Serum uric acid level before and after treatment for both groups (A and B).	2 week before and 2 week after	a sample of blood was used to assess the level of uric acid in the blood for both groups A \& B before and after treatment
Visual analogue scale before and after treatment for both groups (A and B): Chicago, Illinois, USA). The P-value is the degree of significance. A P value less than or equal to 0.05 was considered to be significant.	2 week before and 2 week after	consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be. The patient was asked to mark her pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain intensity .
Digital blood pressure monitor	2 week before and 2 week after	It measures blood pressure (systolic \& diastolic) quickly, is easy to use, reliable, and convenient to carry. The monitor has a display that shows systolic blood pressure and diastolic blood pressure. The machine comes with an arm cuff with an air tube and an air jack for connecting the cuff to the machine