The ATLANTIS Trial
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 06/30/2020 |
| Enviado pela primeira vez: | 09/09/2015 |
| Inscrição estimada enviada: | 09/16/2015 |
| Postado pela primeira vez: | 09/17/2015 |
| Última atualização enviada: | 07/20/2020 |
| Última atualização postada: | 07/22/2020 |
| Data real de início do estudo: | 08/31/2015 |
| Data Estimada de Conclusão Primária: | 06/30/2016 |
| Data Estimada de Conclusão do Estudo: | 12/31/2017 |
Condição ou doença
Intervenção / tratamento
Other: Aquatic Group
Other: aquatic activity plus conventional management
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Aquatic Group Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months | Other: Aquatic Group 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 |
| Other: Control Group Conventional management without aquatic exercise |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: 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. |
Resultado
Medidas de Resultado Primário
1. 4 point drop in modified VCSS [3 months and 2 years]
Medidas de Resultado Secundário
1. Viallta Score [3 months and 2 years]
2. Mortality [2 years]
3. VEINES QOL/Sym [3months and 2 years]
4. Recurrent venous thromboembolic disease [3 months and 2 years]
5. Modified Venous Clinical Severity Score [3months and 2 years]
6. SF 36 questionnaire-PHC [3 months and 2 years]
7. Thigh and leg circumference [3 months and 2 years]
8. "Subjective Index" alteration [3 months and 2 years]
