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

Primary Purpose

Mastectomy; Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Qigong exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

group A

group B

Arm Description

Qigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment.

traditional medical and physical therapy treatment only .

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
March 9, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05286489
Brief Title
Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients
Official Title
Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
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?
Detailed Description
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: 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: 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
Qigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment.
Arm Title
group B
Arm Type
Other
Arm Description
traditional medical and physical therapy treatment only .
Intervention Type
Combination Product
Intervention Name(s)
Qigong exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
microcirculation of blood cells
Description
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.
Time Frame
changes from the baseline at 2 months after treatment
Title
Upper Limb Circumference
Description
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.
Time Frame
changes from the baseline at 2 months after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
as the study for post mastectomy patients it's relevant for 1%
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eman othman, PhD
Phone
0020201120572128
Email
dr.emanothman@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eman othman, PhD
Organizational Affiliation
assistant professor at faculty of physical therapy, Cairo university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gehan el miniawi, PhD
Phone
002020237617691
Email
Info@pt.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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