This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.
A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.
Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:
Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.
The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.
The intensity will be progressively adjusted based on the individual's perceived exertion.
Stage III-IV gastrointestinal cancer diagnosis
Age 18-65
Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery,
Karnofsky performance score 80 and above,
Musculoskeletal disorder
Neurological disorder
Severely impaired hematological capacity
History of cardiac disease
Parallel
Exercise
Other interventionSupervised Aerobic Exercises: Conducted every two weeks, three days a week (on days 11-13 post-systemic treatment). The supervised aerobic exercises will consist of 20 minutes on a treadmill at a heart rate corresponding to 55-75% of the Karvonen formula. Warm-up and cool-down will be performed at 30-40% of the Karvonen heart rate for 5 minutes. Supervised Resistance Exercises: Conducted every two weeks on consecutive days (days 11 and 13 post-systemic treatment). Resistance training will involve 12 different exercises targeting major muscle groups, using body weight and resistance bands, at an effort level of 5-7 on the Borg scale, with 8-12 repetitions and 1-3 sets. The intensity will be progressively adjusted based on the individual's perceived exertion. On weeks without supervised exercises, participants will follow a home exercise program that includes breathing exercises, walking for 20-30 minutes, and resistance exercises.
Evaluation of Demographic and Clinical Information
Age, gender, occupation, education status, marital status, medical history, family medical history, medications used, smoking and exercise habits, clinical information about cancer (diagnosis date, cancer stage, treatment received, and treatment start and end times) will be recorded.
Weight Assessment
Weight change in a certain period and percentage of initial weight are used to determine weight loss. Weight loss of 5%, 10% or 20% in a certain period is associated with an increased risk of malnutrition. The participants' weights will be recorded in kilograms.
Height Assessment
The participants' heights will be recorded in centimeters.
Body Mass Index Assessment Body Mass Index Assessment
The participants' Body Mass Index (BMI) values will be recorded in kg/m² (kilograms per square meter).
Performance Assessment
Functional status will be assessed using the Karnofsky Performance Status (KPD) scale. It is considered the gold standard of performance measurement for cancer patients. Individuals will rate their functional status using the KPD scale, which ranges from 30 (I feel severely disabled and need to be hospitalized) to 100 (I feel normal; I have no complaints or symptoms). In the literature, it is generally accepted that individuals who score 70 points and above have adequate functional status. This score indicates that the individual is at a level where they can care for themselves, but their normal activity has decreased and they are unable to do active work.
Evaluation of Symptoms
The Edmonton Symptom Assessment Scale will be used to evaluate the symptoms of participants in both groups. The symptoms included in the scale are pain, fatigue, drowsiness, nausea, loss of appetite, dyspnea, depression, anxiety, feeling unwell and other problems. The severity of each symptom is scored between 0 and 10. A score of 0 indicates no symptoms, while a score of 10 indicates that the symptom is felt very severely.
Frailty Assessment
Morley et al. found that the five-item 'FRAIL Scale' was effective in detecting frailty. In addition to the patient's general health status, the questionnaire evaluates with questions about comorbidities; patients receive zero or one point according to the answer given for each question. A total of 0 is considered normal (non-frail), 1-2 is pre-frail and a score of \>2 is frail. The validity and reliability of the questionnaire in Turkish was demonstrated by Hymabaccus et al. in 2017.
Assessment of Cancer-Related Fatigue
The Fatigue Severity Scale (FSS) will be used to assess the participants' level of cancer-related fatigue. FSS is a scale consisting of 9 questions that assess fatigue. Each item is scored between 0 and 7. The total score is divided by 9 and if the mean is \<4, it is assessed as no fatigue, if \>4, it is assessed as fatigue. The FSS Turkish form, which has been validated and validated as reliable, will be used.
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