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CompletedNCT04824807Updated Feb 15, 2023

Effects of Clinical Pilates and Yoga Training in Lymphedema

An interventional study of Yoga and Clinical Pilates in Lymphedema and Exercise, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Lymphedema
  • Exercise

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Keywords

  • Pilates
  • Yoga
  • Volumetric measurement
  • Muscle Strength Dynamometer
  • Respiratory Function Tests
03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 403 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 136 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • 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 · Other: An educational booklet

  • 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: Yoga · Other: An educational booklet

  • 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

Interventions

  • OtherYoga

    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.

    Also known as: Exercises program

  • OtherClinical 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.

    Also known as: Exercises program

  • OtherAn educational booklet

    Only educational booklets will be given to the control group

    Also known as: No treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: eight weeks

Secondary outcomes

  1. 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.

    Time frame: eight weeks

  2. 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.

    Time frame: eight weeks

  3. 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.

    Time frame: eight weeks

  4. 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.

    Time frame: eight weeks

  5. 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.

    Time frame: eight weeks

07

Study locations

1 site
  • Eastern Mediterranean University
    Famagusta, 99450, Cyprus
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04824807
Lead sponsor
Eastern Mediterranean University
Responsible party
Ferdiye Zabit (MSc physiotherapist, Eastern Mediterranean University) — Principal investigator
First posted
Apr 1, 2021
Start date
Oct 29, 2021
Primary completion
Feb 14, 2023
Completion
Feb 14, 2023
Last update
Feb 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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