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

NCT05286489 | Unknown

• 1 other identifier: 00000001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group A

EXPERIMENTAL

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

Combination Product: Qigong exercise

group B

OTHER

traditional medical and physical therapy treatment only .

Combination Product: Qigong exercise

Interventions

Qigong exercise 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 A; group B

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: as the study for post mastectomy patients it's relevant for 1%
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• eman othman, PhD

  assistant professor at faculty of physical therapy, Cairo university

  STUDY CHAIR

Central Study Contacts

eman othman, PhD

CONTACT

0020201120572128; dr.emanothman@yahoo.com

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: professor

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after publication
• Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.

Locations

EG (1)