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Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE.

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Supervised Training
Individually tailored home program
Sponsored by
Gulf Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer survivor, Quality of life, Cardiorespiratory health, Physical rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Thumbay Medical City, GMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Therapy Intervention

Control Group

Arm Description

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.

This group will continue with their routine life and will receive standard care given by the hospital.

Outcomes

Primary Outcome Measures

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.
Quality of Research
The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).

Secondary Outcome Measures

Full Information

First Posted
August 22, 2023
Last Updated
August 22, 2023
Sponsor
Gulf Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06013527
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulf Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer survivor, Quality of life, Cardiorespiratory health, Physical rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will continue with their routine life and will receive standard care given by the hospital.
Intervention Type
Other
Intervention Name(s)
Supervised Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individually tailored home program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory health
Description
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.
Time Frame
0-5 months
Title
Quality of Research
Description
The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).
Time Frame
0-5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Thumbay Medical City, GMU
City
Al Jurf
State/Province
Ajman
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE.

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