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
About this trial
This is an interventional treatment trial for Gout
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.
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
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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