Mastectomy; LymphedemaNCT05286489
Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients
A study testing Qigong exercise in people with Mastectomy; Lymphedema, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- Qigong exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2022to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy
Giza, 11432
gehan el miniawi, PhD, 002020237617691, Info@pt.cu.edu.eg
About this study
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.
Read more
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?
Read the 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
- Conditions
- Mastectomy; Lymphedema
- Being tested
- Qigong exercise
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong exerciseCombination 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
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Qigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment. Receives: Combination Product: Qigong exercise |
| group B | Other | traditional medical and physical therapy treatment only . Receives: Combination Product: Qigong exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: changes from the baseline at 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed othman, Cairo University
- Investigators
- eman othman, PhD, Study chair, assistant professor at faculty of physical therapy, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286489
- Sponsor's protocol ID
- 00000001
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients
- ClinicalTrials.gov ID
- NCT05286489
- Acronym / sponsor ID
- 00000001
- Conditions
- Mastectomy; Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: Qigong exerciseQigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment. |
| group B | Other | Combination Product: Qigong exercisetraditional medical and physical therapy treatment only . |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong exerciseThe 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 | Combination product | group A, group B |
Primary outcome
microcirculation of blood cells
Time frame: changes from the baseline at 2 months after treatment
* 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
Time frame: changes from the baseline at 2 months after treatment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Yes. 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.
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IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
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Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
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Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eman othman, PhD study chair
assistant professor at faculty of physical therapy, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong exercise in people with Mastectomy; Lymphedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eman othman, PhD (0020201120572128, dr.emanothman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microcirculation of blood cells (time frame: changes from the baseline at 2 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.