Breast CancerNCT04257643
Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy
A study testing aquatic based exercise. and land-based exercise. in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- aquatic based exercise. and land-based exercise.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 30 Nov 2019
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breast cancer with unilateral axillary lymph node excision.
- Mild-moderate degreed lymphedema (stage I and II) .
- Lymphedema with a duration of at least 1 year .
Who cannot join
- Recurrence of cancer.
- Ongoing active oncological treatment.
- Functional disorders hindering participation in exercise programs.
- Open wound at any area of the body.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Aquatic Based Versus Land-based Exercise in Lymph Edema Post-mastectomy: a Prospective Randomized Controlled Trial.
Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment.
Read the detailed description
Group A: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in Group-A had been dealt with water-based exercise was conducted at a hydrotherapy pool for the Eden Health care, cairo, The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water.
Control group, Group B: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in control group had been dealt Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles .
- Conditions
- Breast Cancer
- Being tested
- aquatic based exercise., land-based exercise.
- Keywords
- Aquatic exercise-, Land based exercise, lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic based exercise.Other
exercise under water with the patient standing in a swimming pool, for 60 minswith water to the neck and then practice the arm exercise plus the diaphragmatic breathing exercise. The duration of the exercise programs was selected to be 60 minutes, 3 days per week for 8-week intervention
land-based exercise.Other
land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity .
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | water-based exercise was conducted at a hydrotherapy pool for the Eden Heelth Care,Cairo The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water. Thermo neutral water temperature, 30-32 °C at room temperature. Females were instructed to adjust water depth completely covering clavicles from standing position. Diaphragmatic breathing during exercise routine to assist with lymph fluid clearance. Exercise continuously for 40 to 45 min Full-body warm-up exercise for 10 min and cooling down for 10 minutes. Plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. Receives: Other: aquatic based exercise.; Other: land-based exercise. |
| Control group | Active comparator | Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles Receives: Other: land-based exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb volume measurement:
the patient in a comfortable sitting position, a standard one cm, retractable, the fibreglass tape measure was used to perform circumference measurement. The measurement was made at, 10, 20, 30, and 40 cm above the ulnar styloid process,
Measured: 8 weeks.
Secondary outcomes (1)
Range of Motion
Upper extremity active ROM for shoulder flexion and abduction were assessed in the standing position using a standard goniometric method
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jul 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
- Investigators
- Khadra M Ali, Phd, Principal investigator, Cairo University, Faculty of physical Therapy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257643
- Sponsor's protocol ID
- P.T.REC/012/002615
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aquatic Based Versus Land-based Exercise in Lymph Edema Post-mastectomy: a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04257643
- Acronym / sponsor ID
- P.T.REC/012/002615
- Conditions
- Breast Cancer
- Keywords
- Aquatic exercise-, Land based exercise, lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 6 Feb 2020 (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.
Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment.
Detailed description
Group A: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in Group-A had been dealt with water-based exercise was conducted at a hydrotherapy pool for the Eden Health care, cairo, The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water.
Control group, Group B: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in control group had been dealt Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: aquatic based exercise., Other: land-based exercise.water-based exercise was conducted at a hydrotherapy pool for the Eden Heelth Care,Cairo The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water. Thermo neutral water temperature, 30-32 °C at room temperature. Females were instructed to adjust water depth completely covering clavicles from standing position. Diaphragmatic breathing during exercise routine to assist with lymph fluid clearance. Exercise continuously for 40 to 45 min Full-body warm-up exercise for 10 min and cooling down for 10 minutes. Plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. |
| Control group | Active comparator | Other: land-based exercise.Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Breast cancer with unilateral axillary lymph node excision.
- Mild-moderate degreed lymphedema (stage I and II) .
- Lymphedema with a duration of at least 1 year .
Key exclusion criteria (4 listed)
- Recurrence of cancer.
- Ongoing active oncological treatment.
- Functional disorders hindering participation in exercise programs.
- Open wound at any area of the body.
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 |
|---|---|---|
| aquatic based exercise.exercise under water with the patient standing in a swimming pool, for 60 minswith water to the neck and then practice the arm exercise plus the diaphragmatic breathing exercise. The duration of the exercise programs was selected to be 60 minutes, 3 days per week for 8-week intervention | Other | Experimental group |
| land-based exercise.land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity . | Other | Control group, Experimental group |
Primary outcome
Limb volume measurement:
Time frame: 8 weeks.
the patient in a comfortable sitting position, a standard one cm, retractable, the fibreglass tape measure was used to perform circumference measurement. The measurement was made at, 10, 20, 30, and 40 cm above the ulnar styloid process,
1 secondary outcome
Range of Motion
Time frame: 8 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 6 Feb 2020.
- Individual participant dataSharing planned: Yes
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Khadra M Ali, Phd principal investigator
Cairo University, Faculty of physical Therapy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic based exercise. and land-based exercise. in people with Breast Cancer, 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 3 inclusion and 4 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 6 Feb 2020. 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?
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?
Limb volume measurement: (time frame: 8 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 6 Feb 2020.