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

Primary Purpose

Gout

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication
traditional physical therapy + anti-hyperuricemia medication
Sponsored by
Merit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication

    traditional physical therapy + anti-hyperuricemia medication

    Arm Description

    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.

    consisted of 50 Patients received traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose.

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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 .
    The Borg Rating of Perceived Exertion (RPE) scale
    will be used to measure the level of exertional effort for both groups A & B before and after treatment
    Digital blood pressure monitor
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    July 7, 2022
    Sponsor
    Merit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05454423
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merit University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gout

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    traditional physical therapy + anti-hyperuricemia medication
    Arm Type
    Placebo Comparator
    Arm Description
    consisted of 50 Patients received traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose.
    Intervention Type
    Other
    Intervention Name(s)
    the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication
    Intervention Description
    -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
    Intervention Type
    Other
    Intervention Name(s)
    traditional physical therapy + anti-hyperuricemia medication
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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).
    Description
    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
    Time Frame
    2 week before and 2 week after
    Title
    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.
    Description
    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 .
    Time Frame
    2 week before and 2 week after
    Title
    The Borg Rating of Perceived Exertion (RPE) scale
    Description
    will be used to measure the level of exertional effort for both groups A & B before and after treatment
    Time Frame
    2 week before and 2 week after
    Title
    Digital blood pressure monitor
    Description
    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
    Time Frame
    2 week before and 2 week after

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed A Abd El Rahim, PHD
    Phone
    01006281510
    Email
    toota_1234@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Mabrouk, PHD
    Phone
    01155555088
    Email
    Mohamed.hypa@deraya.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19357323
    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.
    Results Reference
    background
    PubMed Identifier
    19692116
    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.
    Results Reference
    background
    PubMed Identifier
    27112094
    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.
    Results Reference
    background

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

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