Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effetti dell'allenamento aerobico e di resistenza negli individui con cachessia tumorale (Exercise)

1 novembre 2026 aggiornato da: Ezgi Ergin, Dokuz Eylul University

Indagine sugli effetti dell'allenamento aerobico e di resistenza in individui con cancro gastrointestinale e cachessia: studio randomizzato controllato in cieco singolo

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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

Cancer cachexia is a multifactorial syndrome characterized by progressive functional impairment and loss of skeletal muscle mass, which does not improve with nutritional support. 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.

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 50-75% 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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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,
  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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 50-75% 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 10 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.

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 walking for 20-30 minutes and resistance exercises.

Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluation of Demographic and Clinical Information
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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
Lasso di tempo: At baseline and after 12 weeks of exercise training

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Performance Assessment
Lasso di tempo: At baseline and after 12 weeks of exercise training

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.

At baseline and after 12 weeks of exercise training
Evaluation of Symptoms
Lasso di tempo: At baseline and after 12 weeks of exercise training

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.

At baseline and after 12 weeks of exercise training
Frailty Assessment
Lasso di tempo: At baseline and after 12 weeks of exercise training

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.

At baseline and after 12 weeks of exercise training
Assessment of Cancer-Related Fatigue
Lasso di tempo: At baseline and after 12 weeks of exercise training

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.

At baseline and after 12 weeks of exercise training
Assessment of Quality of Life
Lasso di tempo: At baseline and after 12 weeks of exercise training

Quality of life will be assessed using the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ30). The EORTC QLQ-C30 is a valid and reliable cancer-specific quality of life scale. The scale includes three subheadings and 30 questions: general health, functional and symptom scales. In the first 28 questions showing the functional and symptom scales, there are four-point Likert options for each question: not at all (1 point), a little (2 points), quite a bit (3 points), and a lot (4 points). In the 29th question of the scale, the patient is asked to score their health from 1 to 7 (1: very poor and 7: excellent); and in the 30th question, they are asked to evaluate their general quality of life. The scores obtained from all questions of the scale range from 0 to 100 points.

At baseline and after 12 weeks of exercise training

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Didem Karadibak, PhD, Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 dicembre 2024

Completamento primario (Effettivo)

30 giugno 2026

Completamento dello studio (Effettivo)

3 agosto 2026

Date di iscrizione allo studio

Primo inviato

2 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2024

Primo Inserito (Effettivo)

17 dicembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi