Chronic Venous Hypertension Due to Deep Vein ThrombosisATLANTISNCT02553720
The ATLANTIS Trial
A study testing exercise in water and aquatic activity plus conventional management in people with Chronic Venous Hypertension Due to Deep Vein Thrombosis and Venous Reflux, run by Arizona Cardiovascular Consultants at 1 site in United States.
Trial summary
The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Hypertension Due to Deep Vein Thrombosis, Venous Reflux
- What is being tested?
- exercise in water and aquatic activity plus conventional management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years; a Villalta score of ˃5 or a modified Venous Clinical Severity Score (VCSS) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months).
- Exclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (DVT), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona cardiovascular consultants
Mesa, Arizona, 85206
About this study
Official title: Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis.
Read the detailed description
Post-thrombotic syndrome (PTS) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (DVT) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.The frequency increases with occlusive iliac venous thrombosis. PTS results in significant morbidity and a staggering toll on health careresources . PTS is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. There are conflicting results on the efficacy of exercise . In general, exercise has been useful in activation of the muscle pump and improvement of symptoms. There are no data about exercise in a swimming pool. Both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. Furthermore with less effect of gravity, absorption of dependent edema would be faster. Dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. There are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.
- Being tested
- exercise in water, aquatic activity plus conventional management
- Keywords
- Post thrombotic syndrome, Chronic venous insufficiency
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise in waterOther
Also called aquatic activity
The patients will be instructed to perform walking or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
aquatic activity plus conventional managementOther
walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Group | Experimental | Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months Receives: Other: exercise in water; Other: aquatic activity plus conventional management |
| Control Group | Other | Conventional management without aquatic exercise Receives: Other: aquatic activity plus conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 point drop in modified VCSS
Modified VCSS score at baseline, 3 m and 2 years.
Measured: 3 months and 2 years
Secondary outcomes (8)
Viallta Score
Changes in the Vllalta scoring system
Measured: 3 months and 2 years
Mortality
Development of death at follow up.
Measured: 2 years
VEINES QOL/Sym
changes of time velocity integral of the spectral Doppler waveform.
Measured: 3months and 2 years
Recurrent venous thromboembolic disease
Measured objectively by venous duplex or CT angiography or V/Q scan if indicated
Measured: 3 months and 2 years
Modified Venous Clinical Severity Score
Changes in absolute scores before and after intervention
Measured: 3months and 2 years
SF 36 questionnaire-PHC
Changes in score before and after intervention
Measured: 3 months and 2 years
Thigh and leg circumference
Changes in circumference before and after intervention
Measured: 3 months and 2 years
"Subjective Index" alteration
Changes in score before and after intervention
Measured: 3 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous Hypertension Due to Deep Vein ThrombosisStudies 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
- Model description
- A total of 201 patients were randomized with 100 to the Aquatic Group and 101 to the Control Group. At 24 months, 91 patients had completion of evaluation in the Aquatic Group and 90 patients in the Control Group.
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona Cardiovascular Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- A.T. Still University of Health Sciences
- Responsible party
- Principal investigator, Mohsen Sharifi MD, Arizona Cardiovascular Consultants
- Investigators
- Mohsen SHARIFI, M.D., Principal investigator, Arizona Cardiovascular Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553720
- Sponsor's protocol ID
- ArizonaCC
- Acronym
- ATLANTIS
- Status last verified
- Jul 2020
- First submitted
- 10 Sep 2015
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kahn SR, Shapiro S, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome - Authors' reply. Lancet. 2014 Jul 12;384(9938):130-1. doi: 10.1016/S0140-6736(14)61160-0. No abstract available.
PubMed 25016993CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration; Dennis M, Sandercock P, Reid J, Graham C, Forbes J, Murray G. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet. 2013 Aug 10;382(9891):516-24. doi: 10.1016/S0140-6736(13)61050-8. Epub 2013 May 31.
PubMed 23727163Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PubMed 15183623Sharifi M, Bay C, Mehdipour M, Sharifi J; TORPEDO Investigators. Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial: midterm results. J Endovasc Ther. 2012 Apr;19(2):273-80. doi: 10.1583/11-3674MR.1.
PubMed 22545895
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
- ClinicalTrials.gov ID
- NCT02553720
- Acronym / sponsor ID
- ATLANTIS / ArizonaCC
- Keywords
- Post thrombotic syndrome, Chronic venous insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Arizona Cardiovascular ConsultantsUniversity, hospital or other
- Collaborators
- A.T. Still University of Health Sciences
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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 test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis.
Detailed description
Post-thrombotic syndrome (PTS) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (DVT) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.The frequency increases with occlusive iliac venous thrombosis. PTS results in significant morbidity and a staggering toll on health careresources . PTS is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. There are conflicting results on the efficacy of exercise . In general, exercise has been useful in activation of the muscle pump and improvement of symptoms. There are no data about exercise in a swimming pool. Both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. Furthermore with less effect of gravity, absorption of dependent edema would be faster. Dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. There are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 201 patients were randomized with 100 to the Aquatic Group and 101 to the Control Group. At 24 months, 91 patients had completion of evaluation in the Aquatic Group and 90 patients in the Control Group.
| Arm | Type | Receives |
|---|---|---|
| Aquatic Group | Experimental | Other: exercise in water, Other: aquatic activity plus conventional managementConventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months |
| Control Group | Other | Other: aquatic activity plus conventional managementConventional management without aquatic exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age>18 years; a Villalta score of ˃5 or a modified Venous Clinical Severity Score (VCSS) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months).
- Exclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (DVT), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| exercise in waterAlso: aquatic activityThe patients will be instructed to perform walking or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management | Other | Aquatic Group |
| aquatic activity plus conventional managementwalking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management | Other | Aquatic Group, Control Group |
Primary outcome
4 point drop in modified VCSS
Time frame: 3 months and 2 years
Modified VCSS score at baseline, 3 m and 2 years.
8 secondary outcomes
Viallta Score
Time frame: 3 months and 2 years
Mortality
Time frame: 2 years
VEINES QOL/Sym
Time frame: 3months and 2 years
Recurrent venous thromboembolic disease
Time frame: 3 months and 2 years
Modified Venous Clinical Severity Score
Time frame: 3months and 2 years
SF 36 questionnaire-PHC
Time frame: 3 months and 2 years
Thigh and leg circumference
Time frame: 3 months and 2 years
"Subjective Index" alteration
Time frame: 3 months and 2 years
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 23 Jul 2020.
- Background: PubMed 25016993Kahn SR, Shapiro S, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome - Authors' reply. Lancet. 2014 Jul 12;384(9938):130-1. doi: 10.1016/S0140-6736(14)61160-0. No abstract available.
- Background: PubMed 23727163CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration; Dennis M, Sandercock P, Reid J, Graham C, Forbes J, Murray G. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet. 2013 Aug 10;382(9891):516-24. doi: 10.1016/S0140-6736(13)61050-8. Epub 2013 May 31.
- Background: PubMed 15183623Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
- Results publication: PubMed 22545895Sharifi M, Bay C, Mehdipour M, Sharifi J; TORPEDO Investigators. Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial: midterm results. J Endovasc Ther. 2012 Apr;19(2):273-80. doi: 10.1583/11-3674MR.1.
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.
Mohsen SHARIFI, M.D. principal investigator
Arizona Cardiovascular Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in water and aquatic activity plus conventional management in people with Chronic Venous Hypertension Due to Deep Vein Thrombosis and Venous Reflux, run by Arizona Cardiovascular Consultants at 1 site in United States.
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 2 inclusion and 0 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 23 Jul 2020. 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 United States. 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?
4 point drop in modified VCSS (time frame: 3 months and 2 years). 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 NCT02553720, which also lists 4 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 23 Jul 2020.