Effects of Aerobic and Resistance Exercise Training in Individuals with Cancer Cachexia

NCT06737692 | Not Yet Recruiting

• 1 other identifier: DEUFTR-ERGIN-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer Cachexia (CC)

Keywords

exercise; cancer; cachexia; aerobic; resistance

Outcome Measures

Primary Outcomes (11)

• 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.

  At baseline and after 12 weeks of exercise training

• 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.

  At baseline and after 12 weeks of exercise training

• Height Assessment

  The participants' heights will be recorded in centimeters.

  At baseline and after 12 weeks of exercise training

• 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).

  At baseline and after 12 weeks of exercise training

• Assessment of Muscle Strength

  Quadriceps femoris muscle strength will be evaluated using a digital dynamometer (Lafayette, USA). The tests will be performed in the sitting position. Muscle strength will be tested in the middle of the joint range of motion, and the maximum isometric contraction will be measured for 5 seconds. The muscle strength measurement will be repeated 3 times on the right and left sides, and the best value obtained will be recorded in kilograms (kg). Hand grip strength will be measured with a hydraulic dynamometer (Jamar, Sammons Preston Rolyan, Chicago, USA). The test will be performed while patients are sitting comfortably with the shoulder adducted, the forearm neutrally rotated, the elbow flexed 90° and the forearm and wrist in a neutral position. Patients will be instructed to perform a maximum isometric contraction. The participants' hand grip strengths will be recorded in kilograms.

  At baseline and after 12 weeks of exercise training

• Assessment of Lower Extremity Performance

  Lower extremity performance will be evaluated with a 30-second sit-to-stand test, in which the number of times a person can sit down and stand up in 30 seconds is recorded.

  At baseline and after 12 weeks of exercise training

• Sarcopenia Assessments

  The steps determined by ESWGOP will be followed in sarcopenia screening. The 5-question SARC-F questionnaire is a rapid screening questionnaire used in sarcopenia assessment. Responses are scored between 0-2 and the total score is between 0-10. A total score of 4 or more indicates the presence of a risk for sarcopenia.

  At baseline and after 12 weeks of exercise training

• Assessment of Muscle and Fat Mass

  Bioelectrical impedance analysis (Inbody 720) will be used for muscle and fat mass assessment. Participants' muscle and fat mass will be recorded in kilograms.

  At baseline and after 12 weeks of exercise training

• Mobility, balance and performance assessment

  For mobility, balance and performance assessment; Timed Up and Go test (TUG) will be used. TUG will be performed by standing up from a chair (sitting height 46 cm), walking 3 m to a line marked on the floor, crossing the line, turning around and walking back, and sitting on a chair. For TUG-cognitive, the individual will be instructed to count backwards by 3 from a random number between 20 and 100 while completing the TUG. The number will be given immediately after the researcher says "go", and errors in subtraction will not be corrected. In TUG-manual, the individual will be asked to pick up and carry a glass full of beans without spilling while completing the TUG. The glass will be placed on a solid surface 90° to the right of the individual while they are sitting, and they will be asked to put the glass back in the same spot before sitting down again.

  At baseline and after 12 weeks of exercise training

• Assessment of Functional Exercise Capacity

  A 6-minute walk test (6 MWT) will be used to assess functional exercise capacity. Participants will be asked to walk as fast as possible on a 30-meter straight corridor in the 6 MWT and the distance covered will be recorded in meters. During 6 MWT, walking distance, speed and cadence will be assessed using a wireless motion detection device (G-Walk, BTS Bioengineering SpA, Italy) attached to the individual's waist using a semi-elastic belt over L4-L5.

  At baseline and after 12 weeks of exercise training

• Assessment of Gait Parameters

  Individuals will be asked to walk as naturally as possible along an 8-meter path at a speed of their own choosing to assess the time-distance parameters of walking. The 8-meter walk test will measure the time-distance parameters of gait, including step length, stance and swing phases, single support and double support phases. During 8-meter walk test, walking distance, speed, cadence and time-distance parameters of gait will be assessed using a wireless motion detection device (G-Walk, BTS Bioengineering SpA, Italy) attached to the individual's waist using a semi-elastic belt over L4-L5.

  At baseline and after 12 weeks of exercise training

Secondary Outcomes (5)

• Performance Assessment

  At baseline and after 12 weeks of exercise training

• Evaluation of Symptoms

  At baseline and after 12 weeks of exercise training

• Frailty Assessment

  At baseline and after 12 weeks of exercise training

• Assessment of Cancer-Related Fatigue

  At baseline and after 12 weeks of exercise training

• Assessment of Quality of Life

  At baseline and after 12 weeks of exercise training

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Exercise

Control group

NO INTERVENTION

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.

Interventions

Exercise OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Neoplasms; Cachexia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Didem Karadibak, PhD

  Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezgi Ergin, M.Sc.

CONTACT

+905063244055; eezgi.eergin@gmail.com

Didem Karadibak, PhD

CONTACT

+905324308010; didem.karadibak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be single-blind, meaning that the Outcomes Assessor and the researcher implementing the exercise program will be different individuals. The Outcomes Assessor will not be aware of which group the participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Cardiopulmonary Physiotherapy, Principal Investigator, Clinical Professor

Model Details: 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 Outcomes Assessor will not know which group the participants belong to.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)