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

July 7, 2022 updated by: Merit University
Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aquatic exercise + Traditional physical therapy + 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.
Other: the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication

-Aquatic exercises: At the beginning of the exercises, aquatic exercises technique was educated to the participants out of water. Then, the aquatic exercises were conducted in a chest warm pool (28-30°C) for 30 minutes, three sessions a week for eight weeks.

-Traditional physical therapy programs : which included using hot packs (20 minutes), ultrasound (5 minutes), and electrotherapy using TENS (15 minutes) in addition to stretching exercises for the calf, hamstring muscles and big toes and strengthening exercises for the quadriceps muscles for 30 minutes". The stretching exercises were performed in 3 weekly sessions over 8 weeks, each with a 30 second holding and a 30-second relaxation repeated three times. One group of strengthening exercises consisted of 10 repeats with a 5 second holding
Placebo Comparator: 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.
Other: traditional physical therapy + anti-hyperuricemia medication
traditional physical therapy programs, which included using hot packs (20 minutes), ultrasound (5 minutes), and electrotherapy using TENS (15 minutes) in addition to stretching exercises for the calf, hamstring muscles and big toes and strengthening exercises for the quadriceps muscles for 30 minutes". The stretching exercises were performed in 3 weekly sessions over 8 weeks, each with a 30 second holding and a 30 second relaxation repeated three times. One group of strengthening exercises consisted of 10 repeats with a 5 second holding17.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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
2 week before and 2 week after
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.
Time Frame: 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 .
2 week before and 2 week after
The Borg Rating of Perceived Exertion (RPE) scale
Time Frame: 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
2 week before and 2 week after
Digital blood pressure monitor
Time Frame: 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
2 week before and 2 week after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A Eon gout

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gout

Clinical Trials on the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe