Combined Upper Extremity Resistance and Aerobic Exercise Training in Patients With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorHacettepe University
About this trial
According to updated data from the International Agency for Research on Cancer (IARC) for 2022, breast cancer in women is responsible for one in four cancer cases and one in six cancer deaths worldwide and is the second leading cause of global cancer incidence, accounting for 11.6% of all cancer cases, and the fourth leading cause of cancer deaths worldwide, accounting for 6.9% of all cancer deaths. During or after breast cancer treatments, there is exposure to a variety of direct (local/regional treatment, systemic treatment and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that may have adverse effects on treatment-related haematological, cardiovascular, pulmonary and musculoskeletal components. Upper limb dysfunction and lymphoedema have been reported to be two of the most common side effects affecting the quality of life of breast cancer patients after breast cancer treatments. The elastic resistance band, which is widely used in strength training, has the advantage of being applied to various classes because it provides resistance angles in various postures and has a low risk of injury. However, few studies have been conducted on elastic resistance band application in patients with breast cancer. At the same time, evidence on the effectiveness of upper extremity aerobic exercise training in patients with breast cancer is limited. Therefore, this study aimed to investigate the effects of upper extremity aerobic exercise training combined with progressive resistance training and upper extremity aerobic exercise training alone on upper extremity exercise capacity, upper extremity functionality, sarcopenia, frailty, quality of life and lymphedema in patients with breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
To be between 18-80 years old,
Volunteering to participate in the research,
At least 15 months after breast cancer surgery,
No problems in reading and/or understanding the scales and being able to co-operate with the tests.
Disqualifiers
Presence of active infection,
Presence of bilateral breast cancer,
History of surgical, neurological or orthopaedic problems that may affect upper extremity functionality other than breast cancer surgery,
Having a neurological disease or other clinical diagnosis that may affect cognitive status,
Trial design
Design model
Parallel
Treatments tested in this trial
Upper Extremity Aerobic Exercise Training
Other intervention12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.
Upper Extremity Progressive Resistance Exercise Training
Other interventionUpper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Upper Extremity Aerobic ExerciseActive comparator 1 intervention
Group B: Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
6 minute Pegboard and Ring Test - 6PBRT
Total number of rings inserted in six minutes
Time frame
One Year2
Maximal Arm Exercise Capacity
VO2peak requirement during arm ergometry will be estimated using MET levels calculated at each power output based on gender at various body weights and will be displayed in ml/kg/min (1 MET = 3.5 ml/kg/min)
Time frame
One YearSecondary outcomes
1
Evaluation of Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score
Time frame
One Year2
Peripheral Muscle Strength
Hand grip strength by hand dynamometer
Time frame
One Year3
Anthropometric Measurements
Arm Circumference
Time frame
One Year4
Comorbidity Assessment
The Charlson Comorbidity Index According to this index developed by the Institute of Medicine, comorbid diseases are assessed according to their severity. is scored. Comorbidities are scored from mild disease state to severe disease state. are given a score of 1, 2, 3, 4, respectively, and the score obtained by summing the scores of comorbid diseases The severity of comorbidity is also calculated according to the weighted score. One point for every ten years over the age of forty (50-59: 1 point, 60-69: 2 points, etc.)
Time frame
One YearSponsors and contacts
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Source ClinicalTrials.gov