Effects of Clinical Pilates and Yoga Training in Lymphedema

February 14, 2023 updated by: Ferdiye Zabit, Eastern Mediterranean University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Famagusta, Cyprus, 99450
        • Eastern Mediterranean University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Pilates Group
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.
Other: Clinical Pilates

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.

Other Names:
  • Exercises program
Other: An educational booklet
Only educational booklets will be given to the control group
Other Names:
  • No treatment
Experimental: Yoga Group
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.
Other: An educational booklet
Only educational booklets will be given to the control group
Other Names:
  • No treatment
Other: Yoga

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.

Other Names:
  • Exercises program
Other: Control Group
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.
Other: An educational booklet
Only educational booklets will be given to the control group
Other Names:
  • No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
upper extremity muscle endurance
Time Frame: eight weeks
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.
eight weeks
upper extremity muscle strength
Time Frame: eight weeks
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.
eight weeks
upper extremity proprioception
Time Frame: eight weeks

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.
eight weeks
upper extremity functions
Time Frame: eight weeks
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.
eight weeks
Quality of Life Questionnaire
Time Frame: eight weeks
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.
eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETK00-2020-0103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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