Postmastectomy LymphedemaNCT06977620
Effect of CKC and WS Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
A study testing Closed kinetic chain exercises, Weight shifting exercises and Complete Decongestive Therapy in people with Postmastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Postmastectomy Lymphedema
- What is being tested?
- Closed kinetic chain exercises, Weight shifting exercises and Complete Decongestive Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 2 Jun 2026
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who had a history of BCRS with upper limb lymphedema. • Age range of 40-60 years.
- The body mass index (BMI) is less than 30 Kg/m2.
- Consciousness and ability to communicate orally or in writing.
- Treatment by unilateral mastectomy with lymph node dissection.
- No obvious abnormal spine morphology or postural abnormalities visible to the naked eye.
- All participants had moderate lymphedema according to the lymphedema severity assessment.
Who cannot join
- Patients with metastases. • Differences between lower limb length.
- Having acute or chronic vestibular, neurological, and orthopedic diseases.
- Surgery related to spine causing limitation of motion.
- Women with psychiatric disorders, reconstructive surgery.
- Bilateral mastectomy. Diagnosis with a neurological, skeletal, or rheumatic disorder or other disease that seriously affects body posture.
- History of bodily injury such as a spinal, shoulder, or neck injury, resulting in permanent alteration of the normal body posture prior to the unilateral mastectomy.
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- Failure to complete follow-up for any reason over the course of the study.
- Peripheral polyneuropathy, cognitive dysfunction.
- Patients taking medication that affects body balance.
- Severe arthritis or orthopedic conditions in their lower extremity
- Poor conditioning, acute pain in any reason,
- Neurological disorders including visual problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. closed kinetic chain (CKC) exercises play a crucial role in enhancing musculoskeletal stability by countering gravitational forces during both rest and movement. weight shifting and balance are fundamental components of functional movement. Proprioceptive training, which focuses on improving body awareness and balance, is essential for developing trunk control
Read the detailed description
Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups.
1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.
1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.
1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks.
1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).
- Conditions
- Postmastectomy Lymphedema
- Being tested
- Closed kinetic chain exercises, Weight shifting exercises, Complete Decongestive Therapy
- Keywords
- postural stability, closed kinetic chain exercises, weight shifting exercises
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed kinetic chain exercisesOther
Also called CKC
Closed kinetic chain (CKC) exercises emphasize weight-bearing movements where the distal segment of the extremity is fixed, and motion occurs as the proximal segment moves over the stabilized distal segment.
Weight shifting exercisesOther
Also called WS
Weight-shifting is a crucial aspect of dynamic postural control, which refers to the ability to maintain one's bodyweight within the base of support. Lateral weight-shifting, in particular, is essential for maintaining posture under dynamic conditions and is commonly performed in various activities of daily living
Complete Decongestive TherapyOther
Also called CDT
CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).
| Study group | Role | What they receive |
|---|---|---|
| Group A (CKC group) | Active comparator | This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks. Receives: Other: Closed kinetic chain exercises; Other: Complete Decongestive Therapy |
| Group B (WS group): | Active comparator | This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks. Receives: Other: Weight shifting exercises; Other: Complete Decongestive Therapy |
| Group C (Combined group) | Active comparator | This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks Receives: Other: Closed kinetic chain exercises; Other: Weight shifting exercises; Other: Complete Decongestive Therapy |
| Group D (control group) | Placebo comparator | This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). Receives: Other: Complete Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesis Balance™ fall prevention app
Patients will be instructed to hold the phone firmly against their sternum and stand with their eyes open, in a semi-tandem stance, for 30 s. The app contains audio and visual instructions on how to prepare for and complete the test as well as an audio cue to indicate test start and stop.
Measured: Eight weeks
Secondary outcomes (2)
Time Up and Go Test (TUG)
Patients will be asked to stand up from a chair with armrests, walk three meters, turn, walk back, and sit down. The time taken to complete this task will be measured in seconds using a stopwatch
Measured: Eight weeks
Functional Reach Test (FRT)
The patient will enter a standing position on a line marked on the floor. An inch tape will be attached to a wall at approximately shoulder height of the subject. The therapist will stand 5-10 feet away from the patient and instruct them to stand close to the wall without touching it, while facing the inch tape, with the shoulder flexed at 90° and the hand in a fist. The therapist will record the starting position at the knuckle of the third metacarpal head on the ruler. The patient will then be instructed to reach as far forward as possible along the length of the tape without moving their feet. The therapist will once again record the location of the knuckle of the third metacarpal.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start30 Apr 2025
- Primary completion20 May 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmastectomy 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
- Model description
- The study will be four-armed, double-blind, parallel-group, randomized control trial. Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups by using simple randomization technique 1:1 ratio to four equal groups according to sample size calculation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Kamal Mousa Mohamed, Cairo University
- Investigators
- Aya Kamal, PHD, Principal investigator, Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977620
- Sponsor's protocol ID
- P.T.REC/012/005746
- Status last verified
- Aug 2026
- First submitted
- 3 May 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication at international journal
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT06977620
- Acronym / sponsor ID
- P.T.REC/012/005746
- Conditions
- Postmastectomy Lymphedema
- Keywords
- postural stability, closed kinetic chain exercises, weight shifting exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 18 May 2025 (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.
Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. closed kinetic chain (CKC) exercises play a crucial role in enhancing musculoskeletal stability by countering gravitational forces during both rest and movement. weight shifting and balance are fundamental components of functional movement. Proprioceptive training, which focuses on improving body awareness and balance, is essential for developing trunk control
Detailed description
Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups.
1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.
1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.
1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks.
1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The study will be four-armed, double-blind, parallel-group, randomized control trial. Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups by using simple randomization technique 1:1 ratio to four equal groups according to sample size calculation
| Arm | Type | Receives |
|---|---|---|
| Group A (CKC group) | Active comparator | Other: Closed kinetic chain exercises, Other: Complete Decongestive TherapyThis group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks. |
| Group B (WS group): | Active comparator | Other: Weight shifting exercises, Other: Complete Decongestive TherapyThis group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks. |
| Group C (Combined group) | Active comparator | Other: Closed kinetic chain exercises, Other: Weight shifting exercises, Other: Complete Decongestive TherapyThis group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks |
| Group D (control group) | Placebo comparator | Other: Complete Decongestive TherapyThis group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women who had a history of BCRS with upper limb lymphedema. • Age range of 40-60 years.
- The body mass index (BMI) is less than 30 Kg/m2.
- Consciousness and ability to communicate orally or in writing.
- Treatment by unilateral mastectomy with lymph node dissection.
- No obvious abnormal spine morphology or postural abnormalities visible to the naked eye.
Key exclusion criteria (12 listed)
- Patients with metastases. • Differences between lower limb length.
- Having acute or chronic vestibular, neurological, and orthopedic diseases.
- Surgery related to spine causing limitation of motion.
- Women with psychiatric disorders, reconstructive surgery.
- Bilateral mastectomy. Diagnosis with a neurological, skeletal, or rheumatic disorder or other disease that seriously affects body posture.
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 |
|---|---|---|
| Closed kinetic chain exercisesAlso: CKCClosed kinetic chain (CKC) exercises emphasize weight-bearing movements where the distal segment of the extremity is fixed, and motion occurs as the proximal segment moves over the stabilized distal segment. | Other | Group A (CKC group), Group C (Combined group) |
| Weight shifting exercisesAlso: WSWeight-shifting is a crucial aspect of dynamic postural control, which refers to the ability to maintain one's bodyweight within the base of support. Lateral weight-shifting, in particular, is essential for maintaining posture under dynamic conditions and is commonly performed in various activities of daily living | Other | Group B (WS group):, Group C (Combined group) |
| Complete Decongestive TherapyAlso: CDTCDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). | Other | Group A (CKC group), Group B (WS group):, Group C (Combined group), Group D (control group) |
Primary outcome
Kinesis Balance™ fall prevention app
Time frame: Eight weeks
Patients will be instructed to hold the phone firmly against their sternum and stand with their eyes open, in a semi-tandem stance, for 30 s. The app contains audio and visual instructions on how to prepare for and complete the test as well as an audio cue to indicate test start and stop.
2 secondary outcomes
Time Up and Go Test (TUG)
Time frame: Eight weeks
Functional Reach Test (FRT)
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Publication at international journal
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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.
Aya Kamal, PHD principal investigator
Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed kinetic chain exercises, Weight shifting exercises and Complete Decongestive Therapy in people with Postmastectomy 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 7 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesis Balance™ fall prevention app (time frame: Eight weeks). 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 7 Aug 2026.