Breast CancerNCT06013527
Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE.
A study testing Supervised Training and Individually tailored home program in people with Breast Cancer, run by Gulf Medical University at 2 sites in United Arab Emirates.
Trial summary
This randomized control trial aims to analyze the changes in cardiovascular endurance and quality of life domains for breast cancer survivors in the United Arab Emirates using a long-term 2-month physical rehabilitation program adapted from the BREX protocol. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supervised Training and Individually tailored home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 1 Jul 2023to 1 Oct 2024
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients suffering from breast cancer who have undergone Chemotherapy, Mastectomy, and cleared for post-surgical physical rehabilitation.
- Age group -18 years to 65 years
- Female patients only (gender predisposition)
- Diagnosed with stage I-stage IIIa breast cancer. (As other stages of cancer include metastasis).
Who cannot join
- Patients diagnosed with prior cardiorespiratory disorders, cognitive dysfunction, and other health problems that would prevent safe participation.
- Active breast cancer patients.
- Participants who engaged in physical activity like the intervention group in any form.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Al Tawam
Abu Dhabi
Thumbay Medical City
Al Jurf, Ajman Emirate
About this study
Official title: Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE - A Randomized Control Trial.
This randomized control trial aims to analyze the changes in cardiovascular endurance and quality of life domains for breast cancer survivors in the United Arab Emirates using a long-term 2-month physical rehabilitation program adapted from the BREX protocol.
Read the detailed description
Cancer is a medical condition where some cells of the body reproduce uncontrollably and metastasize to other parts of the body. The burden of the disease is significantly high both at the global and national levels. In the year 2020, 19.3 million total new cases of cancer were recorded, and cancer deaths were estimated to be 10.0 million, for both males and females. In UAE, cancer was found to be the third leading cause of death. Specifically in UAE, breast cancer was ranked 1 due to its prevalence, incidence, and mortality. Amongst all types of cancers, breast carcinoma is very common among females across the globe which significantly affects their Quality of Life (QoL) with poor cardiovascular tolerance even after the carcinoma has been treated or removed. Thus, the associated morbidity among breast cancer survivors affects all domains of quality of life comprising physical health, psychological health, level of independence, social interactions, and environmental changes.
It is well known that QoL domains are interrelated where physical rehabilitation is of utmost importance as it can help to address all domains. In addition, the "cardiorespiratory systems" are the main functional unit of our circulatory system and provide energy for body movements. Poor cardiovascular endurance has been very commonly reported among breast cancer survivors, which has a direct effect on individuals' level of independence and ability to participate in the social environment thereby adding to overall QoL. Physical rehabilitation forms an important part of breast cancer management pre- and post-surgical. In the pre-surgical phase, rehabilitation can help the individual to sustain the ill effect of post-surgical complications better. However, it is the post-surgical phase that requires more attention and rehabilitation strategies to combat the situation and help the individual regain their functional level near normal. The importance and benefits of physical rehabilitation among breast cancer survivors have been well reported with evidence in the literature.
Integrated structured exercise programs have been defined and prescribed to check their benefits over the QoL domains. In addition, a study reported that while structured exercise programs should focus on improving cardiorespiratory fitness and muscular strength during exercise training, these programs should consider physical activity outside of training, if well-tolerated, to potentially further lower fatigue and improve QOL in cancer survivors. Thus, an individual-centric approach could be more beneficial. Although a recent study reported a higher incidence and prevalence of breast cancer in the UAE population, no published data was found on the application of the recommended exercise regimen, rehabilitation program, and guidelines for breast cancer survivors in the UAE despite a significant level of evidence.
Therefore, the proposed research project aims to improve the QoL domains and Cardiovascular endurance among breast cancer survivors in the United Arab Emirates using physical rehabilitation and recommended exercise programs. An individual-centric approach is intended to maximize the benefits of physical rehabilitation and to match individual needs efficiently.
- Conditions
- Breast Cancer
- Being tested
- Supervised Training, Individually tailored home program
- Keywords
- Breast cancer survivor, Quality of life, Cardiorespiratory health, Physical rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised TrainingOther
Two different classes over alternate weeks twice per week :
- 60-minute step aerobics class (Given week 1,3,5,7)
- 60 minutes circuit training class (Given week 2,4,6,8)
Each class will include warm-up and cool-down periods both lasting 10-15 min. The exercise period of 30 minutes the maximum target RPE would be set at 14-16 on a 20-point BORG scale, a level of exercise that feels "somewhat hard" or "hard" and coincides with about 86-92% of maximal heart rate, 76-85% of maximal VO 2 and 5-7 metabolic equivalents (METs) ideal for improving the related domains of QoL and Cardiovascular endurance (12). During the first 3 weeks, the participants would exercise at a lower level of RPE (approximately 11-13), to adapt to the training and so that newly recruited participants could also join the group without difficulty.
Individually tailored home programOther
The type of home training would mainly consist of endurance training such as walking, Nordic walking, or aerobic training, but it would also include jumps and leaps like step aerobics to promote bone health. The Participants will be asked to perform these thrice per week.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Intervention | Experimental | The intervention group will receive a structured exercise program which will run for 2 months and a follow-up will be done after 3 months. Receives: Other: Supervised Training; Other: Individually tailored home program |
| Control Group | No intervention | This group will continue with their routine life and will receive standard care given by the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory health
A 2-km walk test (UKK walk test, Tampere, Finland) would be done along to evaluate the submaximal Vo2 analysis additionally peak exercise minute ventilation, and direct maximal voluntary ventilation will be assessed to evaluate pulmonary limitation to exercise. This be measured through Spirometry.
Measured: 0-5 months
Quality of Research
The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).
Measured: 0-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Abdul Rashid, Gulf Medical University
- Investigators
- Fatima Abdul Rashid, Principal investigator, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013527
- Sponsor's protocol ID
- IRB-COHS-STD-95-May-2023
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rashid FA, Anwar W, Kandakurti PK, Al Qawasmeh KHA, Latif MF, Tirmazy SH, Omara M, Hazari A. Physical rehabilitation program for cardiorespiratory health and quality of life among breast cancer survivors in UAE: a randomized control trial. BMC Cancer. 2025 Apr 16;25(1):705. doi: 10.1186/s12885-025-14005-2.
PubMed 40241061Rashid FA, Anwar W, Kandakurti PK, Hazari A. Physical rehabilitation program for cardiorespiratory health and quality of life among breast cancer survivors in UAE: protocol for a randomized control trial. Trials. 2024 Jun 4;25(1):354. doi: 10.1186/s13063-024-08192-9.
PubMed 38835046
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE - A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06013527
- Acronym / sponsor ID
- IRB-COHS-STD-95-May-2023
- Conditions
- Breast Cancer
- Keywords
- Breast cancer survivor, Quality of life, Cardiorespiratory health, Physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 28 Aug 2023 (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.
This randomized control trial aims to analyze the changes in cardiovascular endurance and quality of life domains for breast cancer survivors in the United Arab Emirates using a long-term 2-month physical rehabilitation program adapted from the BREX protocol.
Detailed description
Cancer is a medical condition where some cells of the body reproduce uncontrollably and metastasize to other parts of the body. The burden of the disease is significantly high both at the global and national levels. In the year 2020, 19.3 million total new cases of cancer were recorded, and cancer deaths were estimated to be 10.0 million, for both males and females. In UAE, cancer was found to be the third leading cause of death. Specifically in UAE, breast cancer was ranked 1 due to its prevalence, incidence, and mortality. Amongst all types of cancers, breast carcinoma is very common among females across the globe which significantly affects their Quality of Life (QoL) with poor cardiovascular tolerance even after the carcinoma has been treated or removed. Thus, the associated morbidity among breast cancer survivors affects all domains of quality of life comprising physical health, psychological health, level of independence, social interactions, and environmental changes.
It is well known that QoL domains are interrelated where physical rehabilitation is of utmost importance as it can help to address all domains. In addition, the "cardiorespiratory systems" are the main functional unit of our circulatory system and provide energy for body movements. Poor cardiovascular endurance has been very commonly reported among breast cancer survivors, which has a direct effect on individuals' level of independence and ability to participate in the social environment thereby adding to overall QoL. Physical rehabilitation forms an important part of breast cancer management pre- and post-surgical. In the pre-surgical phase, rehabilitation can help the individual to sustain the ill effect of post-surgical complications better. However, it is the post-surgical phase that requires more attention and rehabilitation strategies to combat the situation and help the individual regain their functional level near normal. The importance and benefits of physical rehabilitation among breast cancer survivors have been well reported with evidence in the literature.
Integrated structured exercise programs have been defined and prescribed to check their benefits over the QoL domains. In addition, a study reported that while structured exercise programs should focus on improving cardiorespiratory fitness and muscular strength during exercise training, these programs should consider physical activity outside of training, if well-tolerated, to potentially further lower fatigue and improve QOL in cancer survivors. Thus, an individual-centric approach could be more beneficial. Although a recent study reported a higher incidence and prevalence of breast cancer in the UAE population, no published data was found on the application of the recommended exercise regimen, rehabilitation program, and guidelines for breast cancer survivors in the UAE despite a significant level of evidence.
Therefore, the proposed research project aims to improve the QoL domains and Cardiovascular endurance among breast cancer survivors in the United Arab Emirates using physical rehabilitation and recommended exercise programs. An individual-centric approach is intended to maximize the benefits of physical rehabilitation and to match individual needs efficiently.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Intervention | Experimental | Other: Supervised Training, Other: Individually tailored home programThe intervention group will receive a structured exercise program which will run for 2 months and a follow-up will be done after 3 months. |
| Control Group | No intervention | –This group will continue with their routine life and will receive standard care given by the hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from breast cancer who have undergone Chemotherapy, Mastectomy, and cleared for post-surgical physical rehabilitation.
- Age group -18 years to 65 years
- Female patients only (gender predisposition)
- Diagnosed with stage I-stage IIIa breast cancer. (As other stages of cancer include metastasis).
Key exclusion criteria (3 listed)
- Patients diagnosed with prior cardiorespiratory disorders, cognitive dysfunction, and other health problems that would prevent safe participation.
- Active breast cancer patients.
- Participants who engaged in physical activity like the intervention group in any form.
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 |
|---|---|---|
| Supervised TrainingTwo different classes over alternate weeks twice per week : 1. 60-minute step aerobics class (Given week 1,3,5,7) 2. 60 minutes circuit training class (Given week 2,4,6,8) Each class will include warm-up and cool-down periods both lasting 10-15 min. The exercise period of 30 minutes the maximum target RPE would be set at 14-16 on a 20-point BORG scale, a level of exercise that feels "somewhat hard" or "hard" and coincides with about 86-92% of maximal heart rate, 76-85% of maximal VO 2 and 5-7 metabolic equivalents (METs) ideal for improving the related domains of QoL and Cardiovascular endurance (12). During the first 3 weeks, the participants would exercise at a lower level of RPE (approximately 11-13), to adapt to the training and so that newly recruited participants could also join the group without difficulty. | Other | Physical Therapy Intervention |
| Individually tailored home programThe type of home training would mainly consist of endurance training such as walking, Nordic walking, or aerobic training, but it would also include jumps and leaps like step aerobics to promote bone health. The Participants will be asked to perform these thrice per week. | Other | Physical Therapy Intervention |
Primary outcome
Cardiorespiratory health
Time frame: 0-5 months
A 2-km walk test (UKK walk test, Tampere, Finland) would be done along to evaluate the submaximal Vo2 analysis additionally peak exercise minute ventilation, and direct maximal voluntary ventilation will be assessed to evaluate pulmonary limitation to exercise. This be measured through Spirometry.
Quality of Research
Time frame: 0-5 months
The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).
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 24 Aug 2025.
- Results publication: PubMed 40241061Rashid FA, Anwar W, Kandakurti PK, Al Qawasmeh KHA, Latif MF, Tirmazy SH, Omara M, Hazari A. Physical rehabilitation program for cardiorespiratory health and quality of life among breast cancer survivors in UAE: a randomized control trial. BMC Cancer. 2025 Apr 16;25(1):705. doi: 10.1186/s12885-025-14005-2.
- Derived from this study: PubMed 38835046Rashid FA, Anwar W, Kandakurti PK, Hazari A. Physical rehabilitation program for cardiorespiratory health and quality of life among breast cancer survivors in UAE: protocol for a randomized control trial. Trials. 2024 Jun 4;25(1):354. doi: 10.1186/s13063-024-08192-9.
- Individual participant dataSharing planned: Yes
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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.
Fatima Abdul Rashid principal investigator
Gulf Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Training and Individually tailored home program in people with Breast Cancer, run by Gulf Medical University at 2 sites in United Arab Emirates.
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 4 inclusion and 3 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
Cardiorespiratory health (time frame: 0-5 months). 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?
On the ClinicalTrials.gov record for NCT06013527, which also lists 2 linked publications.
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 24 Aug 2025.