Chronic Venous InsufficiencyCVINCT03562546
The Effect of Structured Exercise on Chronic Venous Insufficiency
A study testing Strength From Within in people with Chronic Venous Insufficiency, run by Shannon Hernon at 1 site in Ireland.
Trial summary
Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Strength From Within
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2018to 28 Feb 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with chronic venous insufficiency and a Comprehensive Classification System for Chronic Venous Disorder (CEAP) Score of 2,3,4.
Who cannot join
- Younger than 18 years
- Painful Ulceration
- Severe Cardiac Condition
- Cardiorespiratory Disease
- Failure of Physical Activity Readiness form
- American College of Sports Medicine (ACSM) Risk Classification: Class C or above
Show all 16Show fewer
- CEAP classification of 5 or 6
- Severe mobility impairment
- Severe imbalance
- Women who are pregnant
- Women who are breastfeeding
- Those who lack capacity to consent
- Those for whom English is not the first language and have difficulty understanding written and/or spoken English
- Diagnosis of diabetes
- Diagnosis of peripheral arterial disease
- Diagnosis of peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Galway Clinic
Galway
Shannon M Hernon, PhD Student, 0867761346, shernon10@gmail.com
Micheál Newell, PhD
About this study
Official title: The Effect of Structured Exercise on Chronic Venous Insufficiency: A Feasibility Trial
Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Exercise therapy has been shown to improve calf muscle pump function and symptoms and may provide additional therapeutic benefits. It has been reported that structured exercise has the ability to improve ankle joint range of motion, calf muscle strength and calf muscle pump function.
Participants will receive the 12-week structured resistance exercise programme, 'Strength from Within', a warm up and cool down, walking programme and range of motion exercises. Participants will complete the Short Form quality of life (SF-36) Health Survey and the venous clinical severity score questionnaire.
Read more
Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements (muscle endurance), isokinetic testing (strength), duplex ultrasound scanning.
A combination of upper and lower body structured exercise as well as, ankle join range of motion and a walking regimen has the potential to have a significant impact on an individual's calf muscle pump function and avoid these potentially harmful side effects of lower body exercise programmes
Read the detailed description
There will be a total of sixty participants recruited for the study, with an anticipation of 40 to complete the study. Participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to ensure that they are able to participate in the structured exercise programme. If the participants' answers "yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q), he/she is ineligible to participate. Participants will also read a participant information leaflet and sign an informed consent before participating in the study. Baseline demographic will be collected at the start of the study. Participants will complete the SF-36 Health Survey at session one and session 2 (week 12). Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements, isokinetic testing, duplex ultrasound screening.
Upon completing baseline testing participants will have the warm-up, cool-down, stretches, all exercise demonstrated and explained to them. Participants will go through each exercise with the principal investigator to ensure understanding. The principal investigator will then describe each section of the "Strength From Within" Booklet. At the end of the first session the participants will be administered their at home structured exercise booklet, recording booklet, resistance band, warm-up and cool-down information sheet and their ankle range of motion information sheet.
The baseline meeting and the week 12 meeting will take roughly 90 minutes to complete all baseline measurements, questionnaires, isokinetic testing and demonstrations. Isokinetic testing will take a total of 32 minutes with resting periods included in the time, baseline measurements including the muscle strength and functional ambulatory measurements will take a duration of 10.5 minutes, demonstration of the home structured exercise programme will take up to 20 minutes, both questionnaires will take 5-minutes total and time left for any other questions or concerns. Extra time will be given at any point during both meetings if needed by the participant.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Strength From Within
- Keywords
- CVI, Calf Muscle Pump Function, Structured Exercise, Varicose Veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength From WithinOther
A 12 week at home structured resistance exercise programme using resistance bands. Participants will also receive a walking programme, a warm up and cool down, and ankle range of motion exercises.
| Study group | Role | What they receive |
|---|---|---|
| Structured Resistance Exercise | Experimental | 12 week at home structured resistance exercise programme ('Strength From Within') using resistance bands. Under the supervision of an experienced exercise specialist. Receives: Other: Strength From Within |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf Muscle Pump Function
Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux
Measured: 12 Weeks
Calf Muscle Strength
Isokinetic Testing- Biodex
Measured: 12 Weeks
Venous Clinical Severity Score
Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made
Measured: 12 Weeks
Secondary outcomes (3)
Ankle Joint Range of Motion
Goniometer
Measured: 12 Weeks
Overall physical strength
Muscle Strength Endurance Testing
Measured: 12 Weeks
Quality of life
SF-36 Short Form Health Survey
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shannon Hernon
- Sponsor type
- University, hospital or other
- Collaborators
- Galway Clinic
- Responsible party
- Sponsor-investigator, Shannon Hernon, National University of Ireland, Galway, Ireland
- Investigators
- Micheál Newell, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562546
- Sponsor's protocol ID
- 369921
- Acronym
- CVI
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
PubMed 15723761O'Donovan K, Bajd T, Grace P, O'Keeffe D, Lyons G. Preliminary Evaluation of Recommended Airline Exercises for Optimal Calf Muscle Pump Activity. EJVES Extra. 2006;12(1):1-5. doi:10.1016/j.ejvsextra.2006.04.001
Dua A, Heller JA. Advanced Chronic Venous Insufficiency. Vasc Endovascular Surg. 2017 Jan;51(1):12-16. doi: 10.1177/1538574416682175. Epub 2016 Dec 26.
PubMed 28024458White-Chu EF, Conner-Kerr TA. Overview of guidelines for the prevention and treatment of venous leg ulcers: a US perspective. J Multidiscip Healthc. 2014 Feb 11;7:111-7. doi: 10.2147/JMDH.S38616. eCollection 2014.
PubMed 24596466Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med. 1988 Mar-Apr;4(2):96-101.
PubMed 3395496Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.
PubMed 8156326Chiesa R, Marone EM, Limoni C, Volonte M, Petrini O. Chronic venous disorders: correlation between visible signs, symptoms, and presence of functional disease. J Vasc Surg. 2007 Aug;46(2):322-30. doi: 10.1016/j.jvs.2007.04.030. Epub 2007 Jun 27.
PubMed 17600668Scott TE, LaMorte WW, Gorin DR, Menzoian JO. Risk factors for chronic venous insufficiency: a dual case-control study. J Vasc Surg. 1995 Nov;22(5):622-8. doi: 10.1016/s0741-5214(95)70050-1.
PubMed 7494366Fowkes FG, Lee AJ, Evans CJ, Allan PL, Bradbury AW, Ruckley CV. Lifestyle risk factors for lower limb venous reflux in the general population: Edinburgh Vein Study. Int J Epidemiol. 2001 Aug;30(4):846-52. doi: 10.1093/ije/30.4.846.
PubMed 11511615Sadick NS. Predisposing factors of varicose and telangiectatic leg veins. J Dermatol Surg Oncol. 1992 Oct;18(10):883-6. doi: 10.1111/j.1524-4725.1992.tb02921.x.
PubMed 1430543Iannuzzi A, Panico S, Ciardullo AV, Bellati C, Cioffi V, Iannuzzo G, Celentano E, Berrino F, Rubba P. Varicose veins of the lower limbs and venous capacitance in postmenopausal women: relationship with obesity. J Vasc Surg. 2002 Nov;36(5):965-8. doi: 10.1067/mva.2002.128315.
PubMed 12422106Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.
PubMed 7822904Browse NL. The etiology of venous ulceration. World J Surg. 1986 Dec;10(6):938-43. doi: 10.1007/BF01658644. No abstract available.
PubMed 3798942Browse N, Burnand K. CAUSE OF VENOUS ULCERATION. The Lancet. 1982;320(8304):932. doi:10.1016/s0140-6736(82)90901-1.
Darvall KA, Sam RC, Adam DJ, Silverman SH, Fegan CD, Bradbury AW. Higher prevalence of thrombophilia in patients with varicose veins and venous ulcers than controls. J Vasc Surg. 2009 May;49(5):1235-41. doi: 10.1016/j.jvs.2008.12.017.
PubMed 19307088
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Exercise on Chronic Venous Insufficiency: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03562546
- Acronym / sponsor ID
- CVI / 369921
- Conditions
- Chronic Venous Insufficiency
- Keywords
- CVI, Calf Muscle Pump Function, Structured Exercise, Varicose Veins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shannon HernonUniversity, hospital or other
- Collaborators
- Galway Clinic
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 19 Jun 2018 (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.
Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Exercise therapy has been shown to improve calf muscle pump function and symptoms and may provide additional therapeutic benefits. It has been reported that structured exercise has the ability to improve ankle joint range of motion, calf muscle strength and calf muscle pump function.
Participants will receive the 12-week structured resistance exercise programme, 'Strength from Within', a warm up and cool down, walking programme and range of motion exercises. Participants will complete the Short Form quality of life (SF-36) Health Survey and the venous clinical severity score questionnaire.
Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements (muscle endurance), isokinetic testing (strength), duplex ultrasound scanning.
A combination of upper and lower body structured exercise as well as, ankle join range of motion and a walking regimen has the potential to have a significant impact on an individual's calf muscle pump function and avoid these potentially harmful side effects of lower body exercise programmes
Detailed description
There will be a total of sixty participants recruited for the study, with an anticipation of 40 to complete the study. Participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to ensure that they are able to participate in the structured exercise programme. If the participants' answers "yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q), he/she is ineligible to participate. Participants will also read a participant information leaflet and sign an informed consent before participating in the study. Baseline demographic will be collected at the start of the study. Participants will complete the SF-36 Health Survey at session one and session 2 (week 12). Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements, isokinetic testing, duplex ultrasound screening.
Upon completing baseline testing participants will have the warm-up, cool-down, stretches, all exercise demonstrated and explained to them. Participants will go through each exercise with the principal investigator to ensure understanding. The principal investigator will then describe each section of the "Strength From Within" Booklet. At the end of the first session the participants will be administered their at home structured exercise booklet, recording booklet, resistance band, warm-up and cool-down information sheet and their ankle range of motion information sheet.
The baseline meeting and the week 12 meeting will take roughly 90 minutes to complete all baseline measurements, questionnaires, isokinetic testing and demonstrations. Isokinetic testing will take a total of 32 minutes with resting periods included in the time, baseline measurements including the muscle strength and functional ambulatory measurements will take a duration of 10.5 minutes, demonstration of the home structured exercise programme will take up to 20 minutes, both questionnaires will take 5-minutes total and time left for any other questions or concerns. Extra time will be given at any point during both meetings if needed by the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structured Resistance Exercise | Experimental | Other: Strength From Within12 week at home structured resistance exercise programme ('Strength From Within') using resistance bands. Under the supervision of an experienced exercise specialist. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with chronic venous insufficiency and a Comprehensive Classification System for Chronic Venous Disorder (CEAP) Score of 2,3,4.
Key exclusion criteria (16 listed)
- Younger than 18 years
- Painful Ulceration
- Severe Cardiac Condition
- Cardiorespiratory Disease
- Failure of Physical Activity Readiness form
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 |
|---|---|---|
| Strength From WithinA 12 week at home structured resistance exercise programme using resistance bands. Participants will also receive a walking programme, a warm up and cool down, and ankle range of motion exercises. | Other | Structured Resistance Exercise |
Primary outcome
Calf Muscle Pump Function
Time frame: 12 Weeks
Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux
Calf Muscle Strength
Time frame: 12 Weeks
Isokinetic Testing- Biodex
Venous Clinical Severity Score
Time frame: 12 Weeks
Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made
3 secondary outcomes
Ankle Joint Range of Motion
Time frame: 12 Weeks
Overall physical strength
Time frame: 12 Weeks
Quality of life
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Background: PubMed 15723761Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
- BackgroundO'Donovan K, Bajd T, Grace P, O'Keeffe D, Lyons G. Preliminary Evaluation of Recommended Airline Exercises for Optimal Calf Muscle Pump Activity. EJVES Extra. 2006;12(1):1-5. doi:10.1016/j.ejvsextra.2006.04.001
- Background: PubMed 28024458Dua A, Heller JA. Advanced Chronic Venous Insufficiency. Vasc Endovascular Surg. 2017 Jan;51(1):12-16. doi: 10.1177/1538574416682175. Epub 2016 Dec 26.
- Background: PubMed 24596466White-Chu EF, Conner-Kerr TA. Overview of guidelines for the prevention and treatment of venous leg ulcers: a US perspective. J Multidiscip Healthc. 2014 Feb 11;7:111-7. doi: 10.2147/JMDH.S38616. eCollection 2014.
- Background: PubMed 3395496Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med. 1988 Mar-Apr;4(2):96-101.
- Background: PubMed 8156326Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.
- Background: PubMed 17600668Chiesa R, Marone EM, Limoni C, Volonte M, Petrini O. Chronic venous disorders: correlation between visible signs, symptoms, and presence of functional disease. J Vasc Surg. 2007 Aug;46(2):322-30. doi: 10.1016/j.jvs.2007.04.030. Epub 2007 Jun 27.
- Background: PubMed 7494366Scott TE, LaMorte WW, Gorin DR, Menzoian JO. Risk factors for chronic venous insufficiency: a dual case-control study. J Vasc Surg. 1995 Nov;22(5):622-8. doi: 10.1016/s0741-5214(95)70050-1.
- Background: PubMed 11511615Fowkes FG, Lee AJ, Evans CJ, Allan PL, Bradbury AW, Ruckley CV. Lifestyle risk factors for lower limb venous reflux in the general population: Edinburgh Vein Study. Int J Epidemiol. 2001 Aug;30(4):846-52. doi: 10.1093/ije/30.4.846.
- Background: PubMed 1430543Sadick NS. Predisposing factors of varicose and telangiectatic leg veins. J Dermatol Surg Oncol. 1992 Oct;18(10):883-6. doi: 10.1111/j.1524-4725.1992.tb02921.x.
- Background: PubMed 12422106Iannuzzi A, Panico S, Ciardullo AV, Bellati C, Cioffi V, Iannuzzo G, Celentano E, Berrino F, Rubba P. Varicose veins of the lower limbs and venous capacitance in postmenopausal women: relationship with obesity. J Vasc Surg. 2002 Nov;36(5):965-8. doi: 10.1067/mva.2002.128315.
- Background: PubMed 7822904Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.
- Individual participant dataSharing planned: Undecided
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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.
Micheál Newell, PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength From Within in people with Chronic Venous Insufficiency, run by Shannon Hernon at 1 site in Ireland.
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 1 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Jun 2018. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Hernon, PhDStudent (+353867761346, shernon10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf Muscle Pump Function (time frame: 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562546, which also lists 35 linked publications.
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 19 Jun 2018.