Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients

PURPOSE: to assess the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.

BACKGROUND: Qigong is a mind-body integrative exercise originating from traditional Chinese medicine and is used to improve health and energy levels through regular training, yet its effects are not empirically assessed.

Qigong may be a potentially beneficial exercise for survivors of breast cancer and could be used to regulate upper limb blood flow and decrease lymphedema. There is lack in knowledge and information in published studies about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.

So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that Qigong exercise has no or limited effect in microcirculation in postmastectomy lymphedema patient.

RESEARCH QUESTION: Does Qigong exercise an effect on microcirculation in postmastectomy lymphedema patient?

Study Overview

• Status: Not yet recruiting
• Conditions: Mastectomy; Lymphedema
• Intervention / Treatment: Combination product: Qigong exercise

Detailed Description

1. Measurement procedure:

   Both methods of measurements will be done before the beginning of the treatment (pre-treatment) then at the end of the study after 2 months of treatment (post treatment) for both groups of the study.

   A-Upper Limb Circumference by manual goniometer

   B- LASER Doppler Imaging:

2. Treatment procedures:

In this study the treatment protocol was presented in the form of an exercise program lasted for 60 minutes, twice weekly for 8 weeks postmastectomy and achieved under the following phases:

1. Warming up phase:

   The main aim of this phase was to get the muscles warm and loose for strength training. The subject has to train for ten minutes aerobic exercise at a mild velocity before the beginning of each exercise session. Warming up helps direct needed blood flow to the muscles and prepares the body for exercise. Warming up is important for preventing injury as well as gaining maximal benefit from the exercise, because loose and warm muscles respond better to the challenge of the program.

2. Exercise phase:

Participants in the experimental group were qigong practitioners. The qigong style they learned is known as 18 Forms Tai Chi Internal Qigong, which is quite popular among Chinese breast cancer patients. It is a kind of physical and mental exercise (internal qigong) that focuses on relaxation, deep breathing, and slow and coordinated movements and uses the mind to guide these movements. There are a total of 18 upper and lower body movements, and all of the techniques are performed while either standing or semi squatting. Qigong practice session was initiated immediately and continued for about 6 minutes. Each participant in the qigong group performed 18 Forms Tai Chi Internal Qigong once and was assessed immediately afterward in sitting (to measure the vascular outcomes) and lying (to measure the upper limb circumference) positions. The control participants were given no specific exercise instruction after the baseline assessment. Instead, they were asked to rest (sit quietly in the laboratory) for 6 minutes and then participated in the post assessment directly

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eman othman, PhD; Phone Number: 0020201120572128; Email: dr.emanothman@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Faculty of Physical Therapy
    • Contact: gehan el miniawi, PhD; Phone Number: 002020237617691; Email: Info@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age from 25-40 years
• with or without adjuvant chemotherapy/ radiotherapy
• had completed conventional treatments of breast cancer
• medically stable
• had lymphedema, defined as a circumference difference greater than 2 cm at any point between the surgical-side upper limb and the contralateral upper limb
• had no known neurological deficit resulting from breast cancer treatment.
• Participants were also able to perform 18 Forms Tai Chi Internal Qigong independently.

Exclusion Criteria: Participants were excluded if they:

• had significant neurological, musculoskeletal, cardiovascular, peripheral vascular, or kidney disorders.
• had recurrent breast cancer or cancer in another organ during the study period.
• did regular exercises other than qigong
• smokers
• received lumpectomy but not mastectomy
• pregnant during the study period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; Qigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment.	Combination product: Qigong exercise; The qigong style they learned is known as 18 Forms Tai Chi Internal Qigong. It is a kind of physical and mental exercise (internal qigong) that focuses on relaxation, deep breathing, and slow and coordinated movements and uses the mind to guide these movements. There are a total of 18 upper and lower body movements, and all of the techniques are performed while either standing or semi squatting. qigong practice session was initiated immediately and continued for about 6 minutes. Each participant in the qigong group performed 18 Forms Tai Chi Internal Qigong once and was assessed immediately afterward in sitting (to measure the vascular outcomes) and lying (to measure the upper limb circumference) positions. The control participants were given no specific exercise instruction after the baseline assessment. Instead, they were asked to rest (sit quietly in the laboratory) for 6 minutes and then participated in the postassessment directly
Other: group B; traditional medical and physical therapy treatment only .	Combination product: Qigong exercise; The qigong style they learned is known as 18 Forms Tai Chi Internal Qigong. It is a kind of physical and mental exercise (internal qigong) that focuses on relaxation, deep breathing, and slow and coordinated movements and uses the mind to guide these movements. There are a total of 18 upper and lower body movements, and all of the techniques are performed while either standing or semi squatting. qigong practice session was initiated immediately and continued for about 6 minutes. Each participant in the qigong group performed 18 Forms Tai Chi Internal Qigong once and was assessed immediately afterward in sitting (to measure the vascular outcomes) and lying (to measure the upper limb circumference) positions. The control participants were given no specific exercise instruction after the baseline assessment. Instead, they were asked to rest (sit quietly in the laboratory) for 6 minutes and then participated in the postassessment directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microcirculation of blood cells	As these blood cells are moving, the reflected light is subject to the Doppler shift, which is a small change in frequency.; When laser light penetrates the tissue under study it is scattered and partly absorbed. Some of the scattered light returns to the tissue surface, where it is registered by a photo detector inside the instrument. This signal is then processed to extract information about the microcirculatory blood flow. According to the Doppler principle, light particles which hit moving blood cells undergo a change in wavelength/frequency (a Doppler shift), while light particles which encounter static structures return unchanged. The perfusion can be calculated since the magnitude and frequency distribution of the doppler shifted light are directly related to the number and velocity of blood cells but unrelated to their direction of movement.	changes from the baseline at 2 months after treatment
Upper Limb Circumference	The circumferences of both arms that represented the participants' lymphedema status were taken at the level of (a) 10 cm proximal to the lateral epicondyle; (b) the elbow joint, right at the lateral epicondyle; (c) 10 cm distal to the lateral epicondyle; and (d) the wrist joint, just distal to the ulnar styloid process. The upper limb circumferences were measured with a cloth measuring tape. The difference in each circumference measurement between the ipsilateral and contralateral arms was calculated to detect a 2 cm between-side difference.	changes from the baseline at 2 months after treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: eman othman, PhD, Assistant Professor at Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 00000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
• IPD Sharing Time Frame: 1 year after publication
• IPD Sharing Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No