Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women

Varicose Veins Clinical Trial

Official title:

Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271798
• Other study ID #: P.T.REC/012/004867
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: April 19, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Mai Saif Elnasr Ghietah, M.Sc. student
• Phone: 01028201991
• Email: Saifelnasrmai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women.

Description:

Varicose veins in the lower extremities present a spectrum of symptoms from cosmetic issues to severe discomfort including telangiectases, reticular veins, edema, pigmentation, and venous ulceration. These veins lead to painful swelling, skin discoloration, and potential complications like thrombosis, and nerve injury, impacting an individual's efficiency and life quality. Exercise, particularly aerobic and resistance training, has shown promise in improving pain severity, functional ability, and venous blood flow.

So, the current study will be conducted to compare between the effect of resistive exercises versus aerobic exercises on varicose veins in postmenopausal women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 19, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion criteria:

• All women suffering from varicose veins.

• Their age will range from 50 to 65 years.

• Their body mass index will range from 25 to 29.9 kg/m2.

• Voluntary acceptance of participation in the study.

Exclusion Criteria:

• Had history of serious vascular disease as deep venous thrombosis.

• Sensory deficient

• Any dermatological condition that interferes with the procedure.

• Any musculoskeletal or neurological disorders.

• Acute or healed ulcer wounds.

• Any heart disease or pulmonary disease.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Other:
• Life style modification advice
The lifestyle modification advice involves several key elements: reducing daily standing periods, avoiding excessive flexion of the knee joint during sitting, weight reduction, addressing cardio-respiratory conditions, incorporating venotonic agents, and utilizing below-knee elastic compression devices. These measures collectively aim to mitigate the development and progression of varicose veins, potentially preventing complications such as deep venous thrombosis and improving overall circulatory health.
• Resistive exercise
Participants in group A will perform resistive exercise. The patients will be instructed to do seated toe raises exercise or standing toe raise exercise. The exercise will be performed for 30 minutes, three times per week for six weeks.
• Aerobic exercises
Participants in group B will perform aerobic exercise. Each session will begin with 10 min of low-intensity treadmill walking for a warm-up. The subsequent aerobic component will involve incline treadmill walking for 20 min at a perceived exertion of 6-7 (i.e., somewhat hard) on Borg's 3-10 scale followed by 10 min of low-intensity treadmill walking for cool down. The exercise will be performed for 30 minutes, three times per week for six weeks.

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak popliteal vein velocity	It will be assessed by Doppler ultrasound scan for each woman in both groups before and after treatment.	6 weeks
Secondary	Visual analogue scale	It will be used to assess the leg pain intensity for each woman in both groups before and after treatment. The visual analogue scale is a 10 cm line with anchor statements on the left (no pain) and on the right (extra pain). Patients will be asked to mark their current pain level on the line.Then, the centimeters will be measured from the left end of the line to the marked point to obtain the score of leg pain intensity.	6 weeks
Secondary	Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20)	It will be used to assess the quality of life for each woman in both groups before and after treatment. Patients will complete the self- questionnaire CIVIQ-20 in the waiting room. The secretary will hand out the questionnaire and collect it once completed. No particular assistance will be provided to patients. This procedure will be chosen on purpose to avoid any interference from an investigator. At study times, symptom severity will be quantified using a four-point scale (0 = absent, 1 = mild, 2 = significant, 3 = severe) for sensation of swelling, cramps and leg heaviness. The scores of CIVIQ-20 range from 0, the worst score, to 100, the best score.	6 weeks
Secondary	6-minute. walk test	It is a sub-maximal test that will be used to assess the aerobic capacity and daily living activity for each woman in both groups before and after treatment procedures.	6 weeks