GoutNCT05454423
Effect of Aquatic Exercise and Traditional Physical Therapy on Gout in Hypertensive Menopausal Women With Hyperuricemia
A study testing the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication and traditional physical therapy + anti-hyperuricemia medication in people with Gout, run by Merit University.
Trial summary
Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication and traditional physical therapy + anti-hyperuricemia medication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 100 patients with gout
- Age between 45 -65 years
- Cooperative patient.
- A physician referred all patients with the diagnosis of gout
Who cannot join
- history of kidney disease such as chronic kidney disease, Cancer patients. Smokers Patients with chronic heart disease.
Trial locations and contacts
No sites are listed yet.
About this study
Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
Read the 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.
- Conditions
- Gout
- Being tested
- the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication, traditional physical therapy + anti-hyperuricemia medication
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medicationOther
-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
traditional physical therapy + anti-hyperuricemia medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication | Experimental | 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. Receives: Other: the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication |
| traditional physical therapy + anti-hyperuricemia medication | Placebo comparator | consisted of 50 Patients received traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose. Receives: Other: traditional physical therapy + anti-hyperuricemia medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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 .
Measured: 2 week before and 2 week after
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
Measured: 2 week before and 2 week after
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
Measured: 2 week before and 2 week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454423
- Sponsor's protocol ID
- A Eon gout
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19357323Richette P, Bardin T. Gout. Lancet. 2010 Jan 23;375(9711):318-28. doi: 10.1016/S0140-6736(09)60883-7. Epub 2009 Aug 17.
PubMed 19692116Dalbeth 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.
PubMed 27112094
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aquatic Exercise and Traditional Physical Therapy on Gout in Hypertensive Menopausal Women With Hyperuricemia
- ClinicalTrials.gov ID
- NCT05454423
- Acronym / sponsor ID
- A Eon gout
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Merit UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
| Arm | Type | Receives |
|---|---|---|
| aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication | Experimental | Other: the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medicationconsisted 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. |
| traditional physical therapy + anti-hyperuricemia medication | Placebo comparator | Other: traditional physical therapy + anti-hyperuricemia medicationconsisted of 50 Patients received traditional physical therapy in addition to anti-hyperuricemia medication (a potent purine xanthine oxidase (XO) inhibitor) in therapeutic dose. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 100 patients with gout
Key exclusion criteria (1 listed)
- history of kidney disease such as chronic kidney disease, Cancer patients. Smokers Patients with chronic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | aquatic exercise + Traditional physical therapy + anti-hyperuricemia medication |
| traditional physical therapy + anti-hyperuricemia medicationtraditional 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. | Other | traditional physical therapy + anti-hyperuricemia medication |
Primary outcome
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
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 .
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 19357323Derby 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.
- Background: PubMed 19692116Richette P, Bardin T. Gout. Lancet. 2010 Jan 23;375(9711):318-28. doi: 10.1016/S0140-6736(09)60883-7. Epub 2009 Aug 17.
- Background: PubMed 27112094Dalbeth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing the Aquatic exercises +Traditional physical therapy programs +anti-hyperuricemia medication and traditional physical therapy + anti-hyperuricemia medication in people with Gout, run by Merit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Abd El Rahim, PHD (01006281510, toota_1234@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 2 week before and 2 week after). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454423, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.