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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Other: Resistive exercise; Other: Aerobic exercises; Other: Life style modification advice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Resistive exercise group): They will receive life style modification advice, in addition to performing resistive exercise three times per week for six weeks.	Other: 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.; 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.
Experimental: Group B (Aerobic exercise group): They will receive the same life style modification advice, in addition to performing aerobic exercise three times per week for six weeks.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Soheir Mahmoud Elkosery, PhD, Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Varicose Veins; Postmenopausal Women; Aerobic Exercises; Resistive Exercises
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: P.T.REC/012/004867

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No