Varicose VeinsNCT06271798
Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women
A study testing Life style modification advice, Resistive exercise and Aerobic exercises in people with Varicose Veins, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Life style modification advice, Resistive exercise and Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 20 May 2024
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- Life style modification advice, Resistive exercise, Aerobic exercises
- Keywords
- Resistive Exercises, Aerobic Exercises, Varicose Veins, Postmenopausal Women
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style modification adviceOther
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 exerciseOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Resistive exercise group): | Experimental | They will receive life style modification advice, in addition to performing resistive exercise three times per week for six weeks. Receives: Other: Life style modification advice; Other: Resistive exercise |
| Group B (Aerobic exercise group): | Experimental | They will receive the same life style modification advice, in addition to performing aerobic exercise three times per week for six weeks. Receives: Other: Life style modification advice; Other: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak popliteal vein velocity
It will be assessed by Doppler ultrasound scan for each woman in both groups before and after treatment.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start20 Feb 2024
- Primary completion5 Apr 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Saif Elnasr Ghietah Hussein, Cairo University
- Investigators
- Soheir Mahmoud Elkosery, PhD, Study chair, Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271798
- Sponsor's protocol ID
- P.T.REC/012/004867
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06271798
- Acronym / sponsor ID
- P.T.REC/012/004867
- Conditions
- Varicose Veins
- Keywords
- Resistive Exercises, Aerobic Exercises, Varicose Veins, Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 22 Feb 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Resistive exercise group): | Experimental | Other: Life style modification advice, Other: Resistive exerciseThey will receive life style modification advice, in addition to performing resistive exercise three times per week for six weeks. |
| Group B (Aerobic exercise group): | Experimental | Other: Life style modification advice, Other: Aerobic exercisesThey will receive the same life style modification advice, in addition to performing aerobic exercise three times per week for six weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Life style modification adviceThe 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. | Other | Group A (Resistive exercise group):, Group B (Aerobic exercise group): |
| Resistive exerciseParticipants 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 | Group A (Resistive exercise group): |
| Aerobic exercisesParticipants 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 | Group B (Aerobic exercise group): |
Primary outcome
Peak popliteal vein velocity
Time frame: 6 weeks
It will be assessed by Doppler ultrasound scan for each woman in both groups before and after treatment.
3 secondary outcomes
Visual analogue scale
Time frame: 6 weeks
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20)
Time frame: 6 weeks
6-minute. walk test
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
Soheir Mahmoud Elkosery, PhD study chair
Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life style modification advice, Resistive exercise and Aerobic exercises in people with Varicose Veins, run by Cairo University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak popliteal vein velocity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.