Effects of Aerobic and Resistance Exercise Training in Individuals with Cancer Cachexia
NCT ID: NCT06737692
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-01
2025-12-31
Brief Summary
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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.
Detailed Description
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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.
The study will be single-blind, meaning the outcome assessor will not know which group the participants belong to.
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.
Supervised Aerobic Exercises: Conducted every two weeks, three days a week. Supervised Resistance Exercises: Conducted every two weeks on consecutive days. On weeks without supervised exercises, participants will follow a home exercise program that includes breathing exercises, walking for 20-30 minutes, and resistance exercises.
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.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise group
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 breathing exercises, walking for 20-30 minutes, and resistance exercises.
Exercise
Supervised 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.
Control group
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.
No interventions assigned to this group
Interventions
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Exercise
Supervised 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.
Eligibility Criteria
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Inclusion Criteria
* 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,
* 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
* Neurological disorder
* Severely impaired hematological capacity
* History of cardiac disease
* Uncontrolled hypertension
* Severe renal insufficiency
* Advanced osteoporosis
* Decreased ability to stand or walk
18 Years
65 Years
ALL
No
Sponsors
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Dokuz Eylul University
OTHER
Responsible Party
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Didem KARADIBAK
Director, Head of Cardiopulmonary Physiotherapy, Principal Investigator, Clinical Professor
Principal Investigators
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Didem Karadibak, PhD
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation
Locations
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Dokuz Eylül University
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Didem Karadibak, PhD
Role: primary
Ezgi Ergin, M.Sc.
Role: backup
Didem Karadibak, PhD
Role: backup
Umit Akay, M.Sc.
Role: backup
Burcu Acikgoz, M.Sc.
Role: backup
Aytac Terzi, MD
Role: backup
Tugba Yavuzsen, PhD, MD
Role: backup
Ilhan Oztop, PhD, MD
Role: backup
Other Identifiers
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DEUFTR-ERGIN-001
Identifier Type: -
Identifier Source: org_study_id