- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00498771
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.
There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).
Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Texas
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Dallas, Texas, États-Unis, 75246
- Baylor Sammons Breast Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Breast cancer patients with Lymphedema
- Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
- Patients undergoing treatment will require written permission from their physician
- Complete an assessment by a licensed physical therapist before beginning the exercise program
- Patients must sign a consent form to participate
Exclusion Criteria:
- Patients undergoing treatment without physician's written permission
- Patients with health problems that contraindicate exercise
- Patients are not eligible if the physical therapy assessment identifies a contraindication to participation
Inclusion of Women and Minorities:
- Men, women and minorities with breast cancer related lymphedema are eligible
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Aquatic Exercise arm
Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly).
Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
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Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly).
Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
|
Aucune intervention: Control - No Exercise Arm
No exercise will be performed in Control arm.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL) at baseline, 6 week, 6 and 12 month.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Reduction of Lymphedema
Délai: baseline, week 6, month 6, and month 12
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Comparison of the circumference and volumetric measurements of the affected limb will be made prior to, midpoint and at completion of the 12 class program.
Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared
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baseline, week 6, month 6, and month 12
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michael Grant, M.D., Baylor Sammons Breast Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 006-116
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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