NCT06013527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 22, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

Breast cancer survivorQuality of lifeCardiorespiratory healthPhysical rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    0-5 months

  • Quality of Research

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

    0-5 months

Study Arms (2)

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.

Other: Supervised TrainingOther: 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.

Interventions

Two 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.

Physical Therapy Intervention

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.

Physical Therapy Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thumbay Medical City

Al Jurf, Ajman Emirate, United Arab Emirates

Location

Al Tawam

Abu Dhabi, United Arab Emirates

Location

Related Publications (2)

  • 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.

    PMID: 40241061BACKGROUND
  • Rashid 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fatima Abdul Rashid

    Gulf Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations