Clinical trial NCT06013527: Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE.
Official title: Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE - A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer survivor
Quality of life
Cardiorespiratory health
Physical rehabilitation
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cardiorespiratory health
timeFrame: 0-5 months
measure: Quality of Research
timeFrame: 0-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Jurf
country: United Arab Emirates
facility: Thumbay Medical City, GMU
state: Ajman
Study officials:
References: