Chronic Venous Insufficiency, CVICVINCT06727968
Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency.
A study testing Compression Stocking, Therapeutic exercise and Self-massage in people with Chronic Venous Insufficiency, CVI, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Venous Insufficiency, CVI
- What is being tested?
- Compression Stocking, Therapeutic exercise and Self-massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 30 Aug 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed of CVI
- aged between 18 and 85 years and
- with mobile or email address to send the study information and follow-up
Who cannot join
- Mental or psychological condition that impairs the study development
- comorbidities that impair the physical activity performance
- surgical interventions during the 6 previous months before the intervention or during the study development
- deep vein thrombosis
- active leg ulcer
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency. a Randomized Controlled Clinical Trial.
The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.
Read the detailed description
This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.
- Conditions
- Chronic Venous Insufficiency, CVI
- Being tested
- Compression Stocking, Therapeutic exercise, Self-massage, Prevention measures
- Keywords
- Therapeutic exercise, Massage, Compression Stocking, Physiotherapy
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression StockingProcedure or surgery
Also called Compression therapy
Wear the compression stockin at least 6-8 hours/day
Therapeutic exerciseProcedure or surgery
Home-based exercise programm based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting, and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day.
Self-massageProcedure or surgery
Self-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system.
Prevention measuresProcedure or surgery
General preventive recommendations, and they were explained to the patient by the primary care physician. Those recommendations were based on the reduction in risk factors described in the Guide of "Recommendations for the management of Chronic Venous Disease in Primary Care" published by Semergen and semFYC.
| Study group | Role | What they receive |
|---|---|---|
| Conventional approach or control group | Experimental | This group were provided with a pamphlet with general preventive recommendations and, in addition, their primary care physicians prescribed to the participants a gradual compression stocking, that exerted maximum pressure on the ankle that progressively decreases towards the proximal part of the extremity and their were instructed to wear it at least 6-8 hours at day. Receives: Procedure: Compression Stocking; Procedure: Prevention measures |
| Multimodal approach or experimental group | Experimental | To the intervention carried out in the control group a home-based program of therapeutic exercise and self-massage presecribed by a physiotherapis was added. Home-based therapeutic exercises were based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day. Self-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system. Receives: Procedure: Compression Stocking; Procedure: Therapeutic exercise; Procedure: Self-massage; Procedure: Prevention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
Was measured through the right and left leg circumference measurement. Four points were marked in both patients' legs (12 cm from the Hallux extreme direction to the heel, 10, 20 and 30 cm from the heel direction to knee) and total volume was calculated using the formula of the sum of all partial volumes squared divided by pi.
Measured: Pre-intervention and after 16 weeks of intervention
Functionality in gait
Was assessed using the 6-Minutes Walking Test (6MWT) that evaluates the maximum distance that the patient is able to walk in 6 minutes. To perform the test, a corridor of 30 meters with a wide enough for patients who need walking aids and at least 30 meters long is required. The place where the 30-meter distance begins and ends will be marked on the floor. Two cones will also be placed, which the patient will walk around.
Measured: Pre-intervention and after 16 weeks of intervention
Physical Activity Level
Was measured using the International Physical Activity Questionnaire (IPAQ) that is an indirect outcome measure that seeks information on the frequency and duration of walking and daily activities that require moderate to vigorous physical effort, as well as time spent sitting during the week and at the weekend.
Measured: Pre-intervention and after 16 weeks of intervention
Prevention measures employed
The prevention measures employed were quantified in a check list of 10 items that included: (1) Use of tight clothing; (2) Use of high-heeled shoes; (3) Lubrication of legs and ankles with self-massage; (4) Avoid direct heat sources on the legs; (5) Hydromassage with cold water; (6) Use of compression stockings; (7) Prevention of chronic constipation; (8) Continued trauma to legs and feet; (9) Elevate legs during the day or night; (10) Avoid long periods of sitting or standing. A total score of 0 implies that none of the venous hygiene measures was carried out, and a score of 10 implies that all of them are fulfilled.
Measured: Pre-intervention and after 16 weeks of intervention
Functionality of lower limbs
The 5 Times Sit to Stand Test (5TSTST) assesses about the functional strength of lower limbs, transitional movements, balance and risk of falling. The test is based on the amount of time it takes a patient to go from a sitting to a standing position 5 times with the arms crossed over the chest. The equipment needed to perform the test is a stopwatch and a chair of standard height.
Measured: Pre-intervention and after 16 weeks of intervention
Secondary outcomes (3)
CVI symptoms and severity
Venous symptoms (fatigue, cramps, heaviness, pain, irritation or tingling), previous venous symptoms, prior thrombosis and venotonic drugs intake. The severity of the CVI was measured too through the Venous Clinical Severity Score (VCSS). VCSS measures 10 clinical descriptors: pain, varicose veins, venous oedema, skin pigmentation, inflammation, induration, number of ulcers, duration of active ulcers, ulcer size and use of compression therapy. The items were scored from 0 to 3, with a total score of 30 points. This study has demonstrated good intra and interobserver reliability and has been widely used in research.
Measured: Baseline
Satisfaction with the treatment
Was registered through a 10-points scored line where 0 points was the worst punctuation in satisfaction and 10 the best.
Measured: After 16 weeks of intervention
Adherence to treatment
CG and EG participants received a diary where they had to take note about when they performed the prescribed interventions (compression shocks, exercise program or massage). A compliment of the 75-100% of the total treatments has considered a very high adherence, between the 50-75% high adherence, between 25-50% low and less than 25% very low.
Measured: After 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Mar 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency, CVIStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Valencia
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727968
- Sponsor's protocol ID
- CVI_Fuensanta
- Acronym
- CVI
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency. a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06727968
- Acronym / sponsor ID
- CVI / CVI_Fuensanta
- Conditions
- Chronic Venous Insufficiency, CVI
- Keywords
- Therapeutic exercise, Massage, Compression Stocking, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital General Valencia
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 11 Dec 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 is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.
Detailed description
This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional approach or control group | Experimental | Procedure: Compression Stocking, Procedure: Prevention measuresThis group were provided with a pamphlet with general preventive recommendations and, in addition, their primary care physicians prescribed to the participants a gradual compression stocking, that exerted maximum pressure on the ankle that progressively decreases towards the proximal part of the extremity and their were instructed to wear it at least 6-8 hours at day. |
| Multimodal approach or experimental group | Experimental | Procedure: Compression Stocking, Procedure: Therapeutic exercise, Procedure: Self-massage, Procedure: Prevention measuresTo the intervention carried out in the control group a home-based program of therapeutic exercise and self-massage presecribed by a physiotherapis was added. Home-based therapeutic exercises were based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day. Self-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed of CVI
- aged between 18 and 85 years and
- with mobile or email address to send the study information and follow-up
Key exclusion criteria (6 listed)
- Mental or psychological condition that impairs the study development
- comorbidities that impair the physical activity performance
- surgical interventions during the 6 previous months before the intervention or during the study development
- deep vein thrombosis
- active leg ulcer
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 |
|---|---|---|
| Compression StockingAlso: Compression therapyWear the compression stockin at least 6-8 hours/day | Procedure or surgery | Conventional approach or control group, Multimodal approach or experimental group |
| Therapeutic exerciseHome-based exercise programm based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting, and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day. | Procedure or surgery | Multimodal approach or experimental group |
| Self-massageSelf-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system. | Procedure or surgery | Multimodal approach or experimental group |
| Prevention measuresGeneral preventive recommendations, and they were explained to the patient by the primary care physician. Those recommendations were based on the reduction in risk factors described in the Guide of "Recommendations for the management of Chronic Venous Disease in Primary Care" published by Semergen and semFYC. | Procedure or surgery | Conventional approach or control group, Multimodal approach or experimental group |
Primary outcome
Edema
Time frame: Pre-intervention and after 16 weeks of intervention
Was measured through the right and left leg circumference measurement. Four points were marked in both patients' legs (12 cm from the Hallux extreme direction to the heel, 10, 20 and 30 cm from the heel direction to knee) and total volume was calculated using the formula of the sum of all partial volumes squared divided by pi.
Functionality in gait
Time frame: Pre-intervention and after 16 weeks of intervention
Was assessed using the 6-Minutes Walking Test (6MWT) that evaluates the maximum distance that the patient is able to walk in 6 minutes. To perform the test, a corridor of 30 meters with a wide enough for patients who need walking aids and at least 30 meters long is required. The place where the 30-meter distance begins and ends will be marked on the floor. Two cones will also be placed, which the patient will walk around.
Physical Activity Level
Time frame: Pre-intervention and after 16 weeks of intervention
Was measured using the International Physical Activity Questionnaire (IPAQ) that is an indirect outcome measure that seeks information on the frequency and duration of walking and daily activities that require moderate to vigorous physical effort, as well as time spent sitting during the week and at the weekend.
Prevention measures employed
Time frame: Pre-intervention and after 16 weeks of intervention
The prevention measures employed were quantified in a check list of 10 items that included: (1) Use of tight clothing; (2) Use of high-heeled shoes; (3) Lubrication of legs and ankles with self-massage; (4) Avoid direct heat sources on the legs; (5) Hydromassage with cold water; (6) Use of compression stockings; (7) Prevention of chronic constipation; (8) Continued trauma to legs and feet; (9) Elevate legs during the day or night; (10) Avoid long periods of sitting or standing. A total score of 0 implies that none of the venous hygiene measures was carried out, and a score of 10 implies that all of them are fulfilled.
Functionality of lower limbs
Time frame: Pre-intervention and after 16 weeks of intervention
The 5 Times Sit to Stand Test (5TSTST) assesses about the functional strength of lower limbs, transitional movements, balance and risk of falling. The test is based on the amount of time it takes a patient to go from a sitting to a standing position 5 times with the arms crossed over the chest. The equipment needed to perform the test is a stopwatch and a chair of standard height.
3 secondary outcomes
CVI symptoms and severity
Time frame: Baseline
Satisfaction with the treatment
Time frame: After 16 weeks of intervention
Adherence to treatment
Time frame: After 16 weeks of intervention
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Stocking, Therapeutic exercise and Self-massage in people with Chronic Venous Insufficiency, CVI, run by University of Valencia at 1 site in Spain.
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 3 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 11 Dec 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 Spain. 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?
Edema (time frame: Pre-intervention and after 16 weeks of intervention). The study lists 5 primary outcomes in all. 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 11 Dec 2024.