LymphedemaNCT04824807
Effects of Clinical Pilates and Yoga Training in Lymphedema
A study testing Yoga, Clinical Pilates and An educational booklet in people with Lymphedema and Exercise, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of our study is to compare the effects of clinical Pilates and yoga training on lymphedema, upper limb muscle strength, proprioception, functions and quality of life in women with lymphedema after breast cancer. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Exercise
- What is being tested?
- Yoga, Clinical Pilates and An educational booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCyprus
- Study dates
- 29 Oct 2021to 14 Feb 2023
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Breast cancer survivors,
- who are between the ages of 35-70,
- who have unilateral mild, moderate or severe
- lymphedema in the upper extremities after breast cancer treatment,
- who have taken any of the Lymphedema treatment methods at least 6 months ago will be included.
Who cannot join
- Presence of metastatic breast cancer,
- Currently receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy),
- Severe heart failure (Class III),
- Infections in extremities (fungal, redness, temperature increase),
- Severe pain in the axillary region (eg: axillary web syndrome,
- reflex sympathetic dystrophy, neuropathy),
- Persons participating in a regular exercise program in the last 6 months will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the Effects of Clinical Pilates and Yoga Training in Women With Lymphedema After Breast Cancer
The aim of our study is to compare the effects of clinical Pilates and yoga training on lymphedema, upper limb muscle strength, proprioception, functions and quality of life in women with lymphedema after breast cancer.
Read the detailed description
A total of 60 post breast cancer lymphedema individuals will be included in our study. The study will be performed in individuals who live in T.R.N.C and who develop mild, moderate or severe lymphedema after breast cancer in the 35-70 age range.
A randomized controlled trial design with three groups were used; 1) A Hatha yoga intervention group, 2) Clinical Pilates intervention group, 3) Control group.
Individuals in the intervention groups will be given 24 sessions of yoga or Clinical Pilates training 3 times a week for 8 weeks. Control group will not receive any treatment. During the training, and control group individuals will be asked to wear compression stockings during the 8 weeks and an educational booklet will be given to the each group.
The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow. Before starting the Clinical Pilates exercise program, the patients will be trained on Pilates exercises and postures. During training, the patients will be taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.
As a result of the research, the data will be analyzed to determine which treatment method is more effective in lymphedematous individuals.
- Conditions
- Lymphedema, Exercise
- Being tested
- Yoga, Clinical Pilates, An educational booklet
- Keywords
- Pilates, Yoga, Volumetric measurement, Muscle Strength Dynamometer, Respiratory Function Tests
- Medical subject headings
- Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Also called Exercises program
The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow.
Exercises: sitting down badrasana, ardha navasana, dhanurasan, setu bandhasana, Urdhva Dhanurasana, Urdhvamukha Svanasana, Virabhadrasana, Warrior Virasana, Supta Virasana, Surya Namaskar, Mayurasana, Padmasana, Bharadvajasana.
Clinical PilatesOther
Also called Exercises program
before starting the clinical Pilates exercise program, the patients were trained on Pilates exercises and postures. During training, the patients were taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.
Exercises: cork screw, toy soldier, kleopatra, the saw,breast stroke preparation, swimming, diamond press - arm openings, scapula isolations, open book, scissors, shoulder bridge.
An educational bookletOther
Also called No treatment
Only educational booklets will be given to the control group
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pilates Group | Experimental | Individuals in the this group will receive 24 sessions of Clinical Pilates training 3 times a week for 8 weeks. During the training, individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. Receives: Other: Clinical Pilates; Other: An educational booklet |
| Yoga Group | Experimental | Individuals in the this group will be given 24 hours of yoga training 3 times a week for 8 weeks. During the training, individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. Receives: Other: Yoga; Other: An educational booklet |
| Control Group | Other | Individuals in the this group will not receive any treatment. Individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. Receives: Other: An educational booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity lymphedema
Bilateral arm volume was measured with the upper extremity volumetric cup.Participants submerged their arm and hand into a water-filled column up to their axilla, and the volume of displaced water was recorded. Due to differences in volumetric measurement between both arms, it will be recorded.
Measured: eight weeks
Secondary outcomes (5)
upper extremity muscle endurance
Muscle endurance will be evaluated by isokinetic dynamometer.For the extremity to be tested in the supine position, when the shoulder is in 90° abduction and the elbow is 90° flexed, the isokinetic force measurements of the shoulder internal and external rotation movements will be performed with an angular velocity of 240° / s at 15 repetitions.
Measured: eight weeks
upper extremity muscle strength
muscle strength will be evaluated by isokinetic dynamometer.For the extremity to be tested in the supine position, when the shoulder is in 90° abduction and the elbow is 90° flexed, the isokinetic force measurements of the shoulder internal and external rotation movements will be performed with an angular velocity of 180° / s at 5 repetitions.
Measured: eight weeks
upper extremity proprioception
upper extremity proprioceptionuwill be evaluated by isokinetic dynamometer. Proprioception tests were performed during active joint position sense, passive joint position sense and kinesthesia.
While the individuals are lying on their back, the shoulder will be positioned in 90° abduction in the coronal plane and the elbow in 90° flexion and fixed at the level of the chest and ankle. proprioception test, subjects were testedwhile lay comfortably down an adjustable bed. To eliminate visual clues and ears closed with headphones to all subjects were blindfolded.shoulder active joint position sense, passive joint position sense and kinesthesia test measurements of 0-45° external rotation movements will be performed with the shoulder in of 90° abduction and the elbow 90° in flexion positıon, with to be 3 repetitions. A pressure splint will be worn to prevent sensory input to the skin in passive joint position sense.
Measured: eight weeks
upper extremity functions
to evaluate upper extremity functions will be done DASH questionnaire.This survey is a disability and symptom scale that evaluates the upper extremity functions in the last week. It contains 30 items regarding symptoms and daily life activities. 21 items provide information about levels of difficulties experienced with the shoulder, arm and hand while carrying out different physical activities, 5 items provide information about pain, tingling, weakness and stiffness during physical activities of differing intensity, and 4 items provide information about social activities, occupation and sleeping disorders. DASH survey scores an a 5-point likert scale and total scores changes in the range of 0-100. It is completed in about 5-7 minutes. The score. A higher score indicates more disabilities and symptoms.
Measured: eight weeks
Quality of Life Questionnaire
to evaluate Quality of Life Questionnaire will be done EORTC QLQ-BR23. It is a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). The total high scores obtained from the QLQ-BR 23 questionnaire with which patients' quality of daily lives is analyzed indicate difficulties in performing daily living activities, functional activities and reduction in the quality of life.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start29 Oct 2021
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdiye Zabit, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824807
- Sponsor's protocol ID
- ETK00-2020-0103
- Status last verified
- Feb 2023
- First submitted
- 10 Mar 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of Clinical Pilates and Yoga Training in Women With Lymphedema After Breast Cancer
- ClinicalTrials.gov ID
- NCT04824807
- Acronym / sponsor ID
- ETK00-2020-0103
- Conditions
- Lymphedema, Exercise
- Keywords
- Pilates, Yoga, Volumetric measurement, Muscle Strength Dynamometer, Respiratory Function Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 1 Apr 2021 (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.
The aim of our study is to compare the effects of clinical Pilates and yoga training on lymphedema, upper limb muscle strength, proprioception, functions and quality of life in women with lymphedema after breast cancer.
Detailed description
A total of 60 post breast cancer lymphedema individuals will be included in our study. The study will be performed in individuals who live in T.R.N.C and who develop mild, moderate or severe lymphedema after breast cancer in the 35-70 age range.
A randomized controlled trial design with three groups were used; 1) A Hatha yoga intervention group, 2) Clinical Pilates intervention group, 3) Control group.
Individuals in the intervention groups will be given 24 sessions of yoga or Clinical Pilates training 3 times a week for 8 weeks. Control group will not receive any treatment. During the training, and control group individuals will be asked to wear compression stockings during the 8 weeks and an educational booklet will be given to the each group.
The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow. Before starting the Clinical Pilates exercise program, the patients will be trained on Pilates exercises and postures. During training, the patients will be taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.
As a result of the research, the data will be analyzed to determine which treatment method is more effective in lymphedematous individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates Group | Experimental | Other: Clinical Pilates, Other: An educational bookletIndividuals in the this group will receive 24 sessions of Clinical Pilates training 3 times a week for 8 weeks. During the training, individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. |
| Yoga Group | Experimental | Other: Yoga, Other: An educational bookletIndividuals in the this group will be given 24 hours of yoga training 3 times a week for 8 weeks. During the training, individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. |
| Control Group | Other | Other: An educational bookletIndividuals in the this group will not receive any treatment. Individuals will be asked to wear compression stockings during the 8 weeks. An educational booklet will be given to the each group. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer survivors,
- who are between the ages of 35-70,
- who have unilateral mild, moderate or severe
- lymphedema in the upper extremities after breast cancer treatment,
- who have taken any of the Lymphedema treatment methods at least 6 months ago will be included.
Key exclusion criteria (7 listed)
- Presence of metastatic breast cancer,
- Currently receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy),
- Severe heart failure (Class III),
- Infections in extremities (fungal, redness, temperature increase),
- Severe pain in the axillary region (eg: axillary web syndrome,
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 |
|---|---|---|
| YogaAlso: Exercises programThe yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow. Exercises: sitting down badrasana, ardha navasana, dhanurasan, setu bandhasana, Urdhva Dhanurasana, Urdhvamukha Svanasana, Virabhadrasana, Warrior Virasana, Supta Virasana, Surya Namaskar, Mayurasana, Padmasana, Bharadvajasana. | Other | Yoga Group |
| Clinical PilatesAlso: Exercises programbefore starting the clinical Pilates exercise program, the patients were trained on Pilates exercises and postures. During training, the patients were taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques. Exercises: cork screw, toy soldier, kleopatra, the saw,breast stroke preparation, swimming, diamond press - arm openings, scapula isolations, open book, scissors, shoulder bridge. | Other | Clinical Pilates Group |
| An educational bookletAlso: No treatmentOnly educational booklets will be given to the control group | Other | Clinical Pilates Group, Control Group, Yoga Group |
Primary outcome
upper extremity lymphedema
Time frame: eight weeks
Bilateral arm volume was measured with the upper extremity volumetric cup.Participants submerged their arm and hand into a water-filled column up to their axilla, and the volume of displaced water was recorded. Due to differences in volumetric measurement between both arms, it will be recorded.
5 secondary outcomes
upper extremity muscle endurance
Time frame: eight weeks
upper extremity muscle strength
Time frame: eight weeks
upper extremity proprioception
Time frame: eight weeks
upper extremity functions
Time frame: eight weeks
Quality of Life Questionnaire
Time frame: eight 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 15 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, Clinical Pilates and An educational booklet in people with Lymphedema and Exercise, run by Eastern Mediterranean University at 1 site in Cyprus.
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 5 inclusion and 7 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
upper extremity lymphedema (time frame: eight 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 15 Feb 2023.