Clinical trial NCT05454423: Effect of Aquatic Exercise and Traditional Physical Therapy on Gout in Hypertensive Menopausal Women With Hyperuricemia
Official title: Effect of Aquatic Exercise and Traditional Physical Therapy on Gout in Hypertensive Menopausal Women With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gout
Lead sponsor: Merit University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 2 week before and 2 week after
measure: 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.
timeFrame: 2 week before and 2 week after
measure: The Borg Rating of Perceived Exertion (RPE) scale
timeFrame: 2 week before and 2 week after
measure: Digital blood pressure monitor
timeFrame: 2 week before and 2 week after
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Derby CA, Crawford SL, Pasternak RC, Sowers M, Sternfeld B, Matthews KA. Lipid changes during the menopause transition in relation to age and weight: the Study of Women's Health Across the Nation. Am J Epidemiol. 2009 Jun 1;169(11):1352-61. doi: 10.1093/aje/kwp043. Epub 2009 Apr 8.
citation: Richette P, Bardin T. Gout. Lancet. 2010 Jan 23;375(9711):318-28. doi: 10.1016/S0140-6736(09)60883-7. Epub 2009 Aug 17.
citation: Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet. 2016 Oct 22;388(10055):2039-2052. doi: 10.1016/S0140-6736(16)00346-9. Epub 2016 Apr 21.