Breast Cancer Clinical Trial
Official title:
Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer: A Randomized, Single-blind, Controlled Trial
| NCT number | NCT04692090 |
| Other study ID # | Yoga-PA |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 6, 2015 |
| Est. completion date | November 5, 2015 |
| Verified date | December 2020 |
| Source | Ege University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this study,we aimed to examine the effects of Hatha yoga on PA and QoL in patients with breast cancer. Patients will be randomized to receive the yoga group and the control group.Hatha yoga will be practiced twice a week for 10 weeks for intervention group.The PA of the patients will be assessed using a body analysis instrument and QoL was evaluated with an EORTC-Q questionnaire both before treatment and at week 10.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | November 5, 2015 |
| Est. primary completion date | November 5, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Patients between the ages of 18 and 70, witha diagnosis of breast cancer Exclusion Criteria: - Patients with recurrent or progressive disease, or with serious heart or pulmonary disease, with uncontrolled hypertension, infection, cognitive function disorder, psychiatric disease or musculoskeletal system conditions that would prevent exercise, and those who had taken part in a regular exercise program |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ege University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase Angle | Phase angle was evaluated with a Tanita body composition monitor (Tanita Corp., Tokyo, Japan). Electrodes are placed on both feet and both hands that send electrical signals from the body to a single independent unit. Voltages are measured at the top of the thumbs on both hands and both heels. A high-frequency electric current (90µA at 50 kHz) is applied, and the Resistance (R) and Reactance (xc) values are measured between the hands and feet. Internal software calculates the phase angle based on the following formula: Phase angle (PhA) = Reactance (xc) / Resistance (R) * (180 / p) | 10 weeks | |
| Secondary | The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire | The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire; This 30-question survey is conducted to evaluate QoL in patients with breast cancer and assesses any symptoms that occurred in the previous two weeks. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS), and symptom scale (SS). High scores in the functional and global health scales indicate a good QoL, while high scores on the symptom scale point to a high level of problems | 10 weeks | |
| Secondary | Arm Volume | Patients were also evaluated for the lymphedema of the limbs is assessed through circumferential and volumetric methods. Circumferential upper limb measurements were carried out with the arm abducted to 30°, starting at the level of the carpometacarpal joint, and at every 5 cm proximal to this point along with both limbs | 10 weeks | |
| Secondary | Body-Mass Index | Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. | 10 weeks |
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