Clinical trial · Interventional
Effects of Aerobic and Resistance Exercise Training in Individuals With Cancer Cachexia
Investigation of the Effects of Aerobic and Resistance Exercise Training in Individuals With Gastrointestinal Cancer and Cachexia: Randomized Controlled Single-Blind Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cachexia (CC) | Cholangiocarcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise group
- description
- The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks. Supervised Aerobic Exercises: Conducted every two weeks, 3 days/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 2 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. On weeks without supervised exercises, participants will follow a home exercise program that includes walking for 20-30 minutes and resistance exercises.
- interventionNames
- Other: Exercise
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants in the control group will be instructed to maintain their daily lifestyle, including physical activity, during their participation in the study. After completion of the study, participants in the control group will be offered a supervised aerobic and resistance exercise program and will be administered the same exercise program.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage III-IV gastrointestinal cancer diagnosis * Age ≥ 18 years * Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery, * Karnofsky performance score 80 and above, * Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (\>5% weight loss in the last 6 months or \>2% weight loss in patients with BMI less than 20 kg/m2 or \>2% weight loss in sarcopenic individuals) Exclusion Criteria: * Musculoskeletal disorder * Neurological disorder * Severely impaired hematological capacity * History of cardiac disease * Uncontrolled hypertension * Severe renal insufficiency * Advanced osteoporosis * Decreased ability to stand or walk
References
Publications (0)
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