NCT05454423

Brief Summary

Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

June 29, 2022

Last Update Submit

July 7, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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 .

    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

    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

    2 week before and 2 week after

Study Arms (2)

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.

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.

Other: traditional physical therapy + anti-hyperuricemia medication

Interventions

-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

aquatic exercise + 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.

traditional physical therapy + anti-hyperuricemia medication

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with gout
  • Age between 45 -65 years
  • Cooperative patient.
  • A physician referred all patients with the diagnosis of gout

You may not qualify if:

  • history of kidney disease such as chronic kidney disease, Cancer patients. Smokers Patients with chronic heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 19357323BACKGROUND
  • 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.

    PMID: 19692116BACKGROUND
  • 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.

    PMID: 27112094BACKGROUND

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Ahmed A Abd El Rahim, PHD

CONTACT

Mohamed Mabrouk, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Aquatic Exercise and traditional physical therapy are effective methods of treatment for gout and hypertension in menopausal women.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 12, 2022

Study Start

July 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07