Breast CancerNCT04692090
Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer
A study testing Yoga in people with Breast Cancer, run by Ege University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2015to 5 Nov 2015
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 70, witha diagnosis of breast cancer
Who cannot join
- 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
About this study
Official title: Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer: A Randomized, Single-blind, Controlled Trial
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.
- Conditions
- Breast Cancer
- Being tested
- Yoga
- Keywords
- Phase Angle, Hatha Yoga, Breast Cancer, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Each class started with a check-in period during which any questions or concerns could be raised, after which the patients were given 5 minutes for seated meditation and 10 minutes for Shavasana (lying down in a restorative position).
The following poses were instructed during the course: standing poses with mountain pose (tadasana), chair pose (utkatasana), extended triangle pose (utthita trikonasana), extended side angle pose (utthita parshvakonasana), warrior 1 (virabhadrasana 1), warrior 2 (virabhadrasana 2) and tree pose (vrikshasana). The intervention was applied twice a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Hatha yoga will be practiced twice a week for 10 weeks Receives: Other: Yoga |
| Control group | No intervention | This group will not have any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 / π)
Measured: 10 weeks
Secondary outcomes (3)
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
Measured: 10 weeks
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
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start6 May 2015
- Primary completion5 Nov 2015
- Study completion5 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Eyigor, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692090
- Sponsor's protocol ID
- Yoga-PA
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer: A Randomized, Single-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT04692090
- Acronym / sponsor ID
- Yoga-PA
- Conditions
- Breast Cancer
- Keywords
- Phase Angle, Hatha Yoga, Breast Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 31 Dec 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: YogaHatha yoga will be practiced twice a week for 10 weeks |
| Control group | No intervention | –This group will not have any intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 70, witha diagnosis of breast cancer
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| YogaEach class started with a check-in period during which any questions or concerns could be raised, after which the patients were given 5 minutes for seated meditation and 10 minutes for Shavasana (lying down in a restorative position). The following poses were instructed during the course: standing poses with mountain pose (tadasana), chair pose (utkatasana), extended triangle pose (utthita trikonasana), extended side angle pose (utthita parshvakonasana), warrior 1 (virabhadrasana 1), warrior 2 (virabhadrasana 2) and tree pose (vrikshasana). The intervention was applied twice a week for 10 weeks. | Other | Yoga Group |
Primary outcome
Phase Angle
Time frame: 10 weeks
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 / π)
3 secondary outcomes
The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire
Time frame: 10 weeks
Arm Volume
Time frame: 10 weeks
Body-Mass Index
Time frame: 10 weeks
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 31 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Breast Cancer, run by Ege University.
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 1 inclusion and 1 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase Angle (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2020.