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Effects of Clinical Pilates and Yoga Training in Lymphedema

Primary Purpose

Lymphedema, Exercise

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Yoga
Clinical Pilates
An educational booklet
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Pilates, Yoga, Volumetric measurement, Muscle Strength Dynamometer, Respiratory Function Tests

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Clinical Pilates Group

Yoga Group

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 10, 2021
Last Updated
February 14, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT04824807
Brief Title
Effects of Clinical Pilates and Yoga Training in Lymphedema
Official Title
The Comparison of the Effects of Clinical Pilates and Yoga Training in Women With Lymphedema After Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Exercise
Keywords
Pilates, Yoga, Volumetric measurement, Muscle Strength Dynamometer, Respiratory Function Tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Pilates Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Other Intervention Name(s)
Exercises program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Pilates
Other Intervention Name(s)
Exercises program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
An educational booklet
Other Intervention Name(s)
No treatment
Intervention Description
Only educational booklets will be given to the control group
Primary Outcome Measure Information:
Title
upper extremity lymphedema
Description
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 Outcome Measure Information:
Title
upper extremity muscle endurance
Description
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
Title
upper extremity muscle strength
Description
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
Title
upper extremity proprioception
Description
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
Title
upper extremity functions
Description
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
Title
Quality of Life Questionnaire
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

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Effects of Clinical Pilates and Yoga Training in Lymphedema

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