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

NCT ID: NCT05286489

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-05-31

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

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

Conditions

Mastectomy; Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

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

Group Type: EXPERIMENTAL

Qigong exercise

Intervention Type: COMBINATION_PRODUCT

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

group B

traditional medical and physical therapy treatment only .

Group Type: OTHER

Qigong exercise

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohamed othman

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

eman othman, PhD

Role: STUDY_CHAIR

assistant professor at faculty of physical therapy, Cairo university

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Central Contacts

eman othman, PhD

Role: CONTACT

dr.emanothman@yahoo.com

0020201120572128

Facility Contacts

gehan el miniawi, PhD

Role: primary

Info@pt.cu.edu.eg

002020237617691

Other Identifiers

00000001

Identifier Type: -

Identifier Source: org_study_id