]>
IRCT20200421047158N1 IRCT 2021-01-07 Islamic Azad University Exploring the effect of combined decongestive therapy and Pilates exercise on the reduction of lymphedema symptom The effect of combined decongestive therapy with and without Pilates exercise on the expression of inflammatory biomarkers and body measurement in breast patients with upper extremity lymphedema 2020-05-30 anticipated 30 Complete https://irct.ir/trial/49532 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In present study, simple randomisation method is used. Using random number table, we selected first number randomly. If the selected number is between 0 and 5, we allocated the subject to intervention group (group A) and when the number is between 6 and 9, patients were allocated to control group (group B).This process was continued to recruit 30 patients. N/A Breast cancer related Lymphedema. Intervention 1: Intervention group: The standard decongestant treatment method combined with selected pilates training was performed for 6 weeks and 5 days per week for 30-40 minutes. warm up exercises included 10 minutes of breathing exercises then the main movements were performed aiming at strengthening arm and shoulder muscles containing rest intervals, thus the exercises continued until fatigue which included 7 exercises in one to three sets for 20 minutes. At the end, stretching and body cooling exercises were performed for 5 minutes. Intervention 2: Control group: Patients in the control group received standard combined decongestive therapy involves manual drainage of lymph nodes which was performed daily (5 days a week) for 3 weeks for a total of 21 sessions. Each session consisted of 40 minutes of manual drainage of lymph nodes, performed by a trained therapist. Appropriate skin care methods were used, including moisturizing as well as using multi-layered short stretch bands. Baby oil was used as a lotion. Yes - There is a plan to make this available What will be shared: After removing all variables related to identification of patients, the data would be shared. Patients has completed the consent from. data related to primary and secondary outcomes would be accessible. When: 6 months after the publication of the first article in reputable journals, data will be available. To whom: The data will be provided to help researchers in their investigations as well as to inform patients about their condition Conditions: Researchers can use the data of this study in their studies to conduct new studies. It will also be provided to patients in order to be aware of their condition. Where to obtain: Roghayeh Mokhtari Hessari, PhD student in sports physiology Phone: 09145884100 Email r.hesari 1353@gmail.com How to obtain: The request for data will be reviewed with the authors and contributors of the project and will be made available to others while maintaining ethical protocols.This process might take up to one month. Comments:
public Roghaye Mokhtari Hesari
No. 30, Saadi 6, Andisheh
Miyane Iran (Islamic Republic of) 5315948331 +98 41 5223 5720 r.hesari1353@gmail.com Islamic Azad University scientific Roghaye Mokhtari Hesari
No. 30, Saadi 6, Andisheh
Miyane Iran (Islamic Republic of) 5315948331 +98 41 5223 5720 r.hesari1353@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients with unilateral lymphedema, stage II Patients without history of using complete decongestive therapy Having no regular exercise during the last six month Menopausal women No infection in the arm and no severe skin redness Not taking anticoagulants No nerve injuries in the upper extremity No history of heart failure No history of kidney disease No paralysis in the hand or arm No cancer recurrence 47 years 65 years Female I89.0 Lymphedema, not elsewhere classified Rehabilitation Treatment - Other Intervention group: The standard decongestant treatment method combined with selected pilates training was performed for 6 weeks and 5 days per week for 30-40 minutes. warm up exercises included 10 minutes of breathing exercises then the main movements were performed aiming at strengthening arm and shoulder muscles containing rest intervals, thus the exercises continued until fatigue which included 7 exercises in one to three sets for 20 minutes. At the end, stretching and body cooling exercises were performed for 5 minutes. Control group: Patients in the control group received standard combined decongestive therapy involves manual drainage of lymph nodes which was performed daily (5 days a week) for 3 weeks for a total of 21 sessions. Each session consisted of 40 minutes of manual drainage of lymph nodes, performed by a trained therapist. Appropriate skin care methods were used, including moisturizing as well as using multi-layered short stretch bands. Baby oil was used as a lotion. Quality of life. Timepoint: Three times: before study, after interventions and one month after treatment and exercise. Method of measurement: Quality of life questionnaire; SF-36. The expression of CA-153. Timepoint: 48 hours before the intervention and at the end of the study. Method of measurement: ELISA Kit. The edema volume. Timepoint: Three times: 48 hours before the intervention, at the end of the study and one month after the intervention. Method of measurement: Volumetric cylinder or volumetric tank or volumetric meter. Shoulder range of motion. Timepoint: Three times: 48 hours before the intervention, at the end of the study and one month after the intervention. Method of measurement: Goniometer. Islamic Azad University Approved 2020-10-18 Sport science Research Institute No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)