- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936241
Effect of Circuit Weight Training on Functional Capacity and Quality of Life in Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast Cancer is the most common cancer among women in Egypt causing 22 percent of all cancer-related female deaths. It is the most commonly diagnosed cancer, accounting for nearly a quarter of all cancer cases globally.
With improvements in early detection, surgery, and adjuvant therapy for breast cancer, long-term survival and cure are becoming possible. Despite providing longer survival with early diagnosis of breast cancer, the treatment leaves sequelae with adverse effects such as influence on functional capacity, fatigue, depression, neuropathic lymphoedema, low immunity, and loss of flexibility. All of these effects end up affecting the quality of life (QoL), Imbalance, gait dysfunction, and falls may have particularly severe consequences in breast cancer survivors due to comorbidities increasing the risk of fall-related injury, secondary decline in physical activity, and subsequent functional decline.
Given the profound effects that imbalance, gait dysfunction, and falls have on functional independence, QOL, and long-term health and survivorship, the treatment or prevention of these symptoms is an essential component of cancer rehabilitation for all survivors.
Furthermore, the need for this study is developed from the lack of quantitative knowledge and information in the published studies about the effect of Circuit Weight Training (CWT) on functional capacity and quality of life in breast cancer patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt
- Alhasnaa Sayed Farouk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female with age between 35-45.
- Body Mass Index (BMI) < 25.
- Patients diagnosed with non-metastatic (Stage 0-III) breast cancer.
- All patients who are treated by neoadjuvant chemotherapy before surgery.
Exclusion Criteria:
- Patients diagnosed with cancer metastasis.
- Patients diagnosed with diseases of the nervous system (Parkinson's disease, peripheral nerve palsy) skeletal system (inflammatory diseases, scoliosis >10 Cobb angle), or rheumatic diseases.
- Patients with any current visual impairment that affected their daily living, vestibular disorder, neurological disorder, cognitive disorder, and any further medical condition that would prohibit them from participating safely.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Circuit weight training and traditional physical therapy program
The participants will do Circuit Weight Training in addition to traditional physical therapy program for 8 weeks
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The Circuit Training protocol will be performed as follows: wall push-up, bridge on floor, single leg bridge, bird dog, windshield wiper, march in place, ball squat, squat with an overhead press, reverse pendulum, jumping rope, and spinal twist, 30-35 minutes, 3 times a week for 8 weeks
The participants will receive traditional physical therapy program in the form of therapeutic exercises to keep daily living activity by restoring the strength of flexors and abductors of the shoulder joint using the shoulder wheel and ladder.
It will be performed 3 times per week for eight weeks
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Active Comparator: Traditional physical therapy program
The participants will receive traditional physical therapy program only for 8 weeks
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The participants will receive traditional physical therapy program in the form of therapeutic exercises to keep daily living activity by restoring the strength of flexors and abductors of the shoulder joint using the shoulder wheel and ladder.
It will be performed 3 times per week for eight weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of quality of life
Time Frame: 8 weeks
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The 12-Item Short Form Survey (SF-12) is the abridged practical form of the SF-36.
It is a widely used screening device for measuring physical, mental, and social well-being to assess quality of life. it consists of 2 components: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12).
Its score ranges between 0-100.
Higher score indicates better health.
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8 weeks
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Assessment of functional capacity
Time Frame: 8 weeks
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The 2-minute step test (TMST) will be used to measure exercise capacity for all participants in the study before and after treatment. The test simply requires that participants march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crest when standing. Performance on the test is defined as the number of right-side steps of the criterion height completed in 2 minutes. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural stability test
Time Frame: 8 weeks
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It will be used to measure static balance by measuring posture sway by using the Biodex balance system.
the overall stability index will be measured; lower score of overall stability index indicates better balance.
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8 weeks
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Limits of stability test
Time Frame: 8 weeks
|
t will be used to measure dynamic balance by using the Biodex balance system.
Higher directional control and excursion scores with lower reaction time indicate better voluntary balance control.
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8 weeks
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Single leg stability test
Time Frame: 8 weeks
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It will be used to assess unilateral balance with progressive instability.
Lower stability indexes represent better single-leg balance and neuromuscular control.
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8 weeks
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Assessment of muscle strength
Time Frame: 8 weeks
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A hand-held dynamometer will be used to assess muscular strength of specific muscles of upper and lower limbs by quantifying the maximum force exerted during specific movement, with higher values indicating greater strength.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maher H Ibrahim, Professor, Cairo University
- Study Chair: Heba A. Abdulghafar, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005445
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
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Case Comprehensive Cancer CenterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
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