NCT04824807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

March 10, 2021

Last Update Submit

February 14, 2023

Conditions

Keywords

PilatesYogaVolumetric measurementMuscle Strength DynamometerRespiratory Function Tests

Outcome Measures

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.

    eight weeks

Secondary Outcomes (5)

  • upper extremity muscle endurance

    eight weeks

  • upper extremity muscle strength

    eight weeks

  • upper extremity proprioception

    eight weeks

  • upper extremity functions

    eight weeks

  • Quality of Life Questionnaire

    eight weeks

Study Arms (3)

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.

Other: Clinical PilatesOther: 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.

Other: YogaOther: 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.

Other: An educational booklet

Interventions

YogaOTHER

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
Yoga Group

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
Clinical Pilates Group

Only educational booklets will be given to the control group

Also known as: No treatment
Clinical Pilates GroupControl GroupYoga Group

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

LymphedemaMotor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc physiotherapist

Study Record Dates

First Submitted

March 10, 2021

First Posted

April 1, 2021

Study Start

October 29, 2021

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations