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Exercise Intervention for Cancer Patients

1 novembre 2022 aggiornato da: Turku University Hospital

Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy

Exhausting chemotherapy, adverse effects of chemotherapy and a lack of information on the benefits of physical exercise are the among the reasons for reduced physical exercise among cancer patients during chemotherapy courses. According to best current knowledge only about 10% of cancer patients in Finland are physically active during cancer treatment. In addition, only 20-30% are physically active after recovery from the treatments (Pylkkänen, 2015). There is only little awareness about the benefits of physical activity during cancer treatments. The purpose of the exercise intervention study is to increase the physical activity of patients who are on chemotherapy.

The study is a pilot trial and has no control group. Internationally, exercise interventions have been studied among cancer patients on treatment for decades. The American College of Sports Medicine (ACSM) recommends that cancer patients should have 150 minutes of endurance exercise per week and at least two bouts of muscle strength exercise per week. Consequently, the exercise intervention study will have a combination of muscle power and endurance training. To reach the weekly recommended level of exercise, the cancer patients in the study will additionally have a weekly home training program containing preferentially endurance training. A literature search shows that no studies on exercise interventions during cancer treatment have been published in Finland. Thus, this thesis carries the wider implication of increasing the general knowledge on the importance of physical activity of cancer patients.

Panoramica dello studio

Descrizione dettagliata

The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home. Data on training at home and other items of physical activity is recorded in a diary. Before the intervention is started, an oncologist will examine the participants condition before brisk physical activity is started. Safety is an important consideration and a nurse will examine the patients before each bout of exercise. A nurse will be present during the entire time of the exercise. A physician is always available for consultations by phone.

Before the intervention starts, baseline measurements will be made in the laboratories of physical exercise in the Tyks Hospital and the Turku University of Applied Sciences. At baseline, endurance, muscle power, balance and body composition will be evaluated and recorded. Endurance will be measured with a submaximal treadmill test. Muscle power will be assessed by a dynamic elevation test, hand pressure test, the lower extremities by repeated squatting-standing and by rising to stand on the toes. Balance is measured in the specific sway platform (one leg and both legs standing). The patients will be asked to fill questionnaires on quality of life (QLQ-c30) and fatigue (FACIT-F) before and after the intervention. The patients will fill in their exercise diaries from the very moment their participation has been decided until the end of the intervention. After exercise intervention the patients also fill the feedback-questionnaire.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

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

      • Turku, Finlandia, 20521
        • Turku University Hospital

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • cancer patients in the age of 18-70
  • in the early phase of chemotherapy
  • first line chemotherapy
  • active way of treating cancer
  • solid tumor (breast cancer, prostata cancer, colon cancer and melanoma)
  • Finnish-speaking
  • z=0-1 (no aids)
  • capable travelling to University hospital for 8 weeks twice a week
  • normal or poor physical activity background

Exclusion Criteria:

  • exercise contraindications, like severe respiratory or circulatory system disease (eg. heart attack <3)
  • brain or bone metastasis
  • heterogenous group (max 4 patients per cancer diagnose)
  • thrombocytopenia
  • leukocytopenia
  • immuno-oncological treatments
  • really "athlete patients"

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: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Exercise intervention
The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home. Data on training at home and other items of physical activity is recorded in a diary.
The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
physical activity changes in diary
Lasso di tempo: 0 and 8 weeks,
Does this exercise intervention model works for cancer patients to increase the amount of physical activity and to achieve the cancer patients exercise recommendations? (especially home-exercising)
0 and 8 weeks,
questionnaire-feedback from cancer patients
Lasso di tempo: 0 and 8 weeks
Does this exercise intervention model works for cancer patients to change the amount of physical activity? Patients subjective feedback about the first exercise group model in special health care. The questions are formed in quantitative way.
0 and 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of life questionnaire (EORTC QLQ-c30)
Lasso di tempo: 0 and 8 weeks
Does the guided exercise intervention (physical activity) affect the patients quality of life during chemotherapy? The scales and single-item measures range in score from 0 to 100. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The scale consists of three different part.
0 and 8 weeks
Fatigue questionnaire (FACIT-F)
Lasso di tempo: 0 and 8 weeks
Does the guided exercise intervention (physical activity) affect the patients fatigue during chemotherapy? The score range: 0-52 points. The bigger points the worse fatigue or more symptoms.
0 and 8 weeks
Body composition in cancer patients general view (In-Body-device)
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in the body composition of cancer patients on chemotherapy? The device measures body mass index, fluid, fat and muscle changes. We follow up the changes in general view.
0 and 8 weeks
Endurance (submaximal treadmill test)
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in endurance of cancer patients on chemotherapy?
0 and 8 weeks
Functional muscle power test - dynamic elevation test for upper arms
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
0 and 8 weeks
Functional muscle power test - hand pressure test
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
0 and 8 weeks
Functional muscle power test - the lower extremities by repeated squatting-standing
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
0 and 8 weeks
Functional muscle power test - the lower extremities by rising to stand on the toes
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
0 and 8 weeks
Functional muscle power test - plank-test for the body
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
0 and 8 weeks
Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)
Lasso di tempo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in the balance of cancer patients on chemotherapy?
0 and 8 weeks

Collaboratori e investigatori

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

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)

17 febbraio 2020

Completamento primario (Effettivo)

16 aprile 2020

Completamento dello studio (Effettivo)

8 maggio 2020

Date di iscrizione allo studio

Primo inviato

14 ottobre 2019

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2019

Primo Inserito (Effettivo)

5 novembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 novembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2022

Ultimo verificato

1 novembre 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • T306/2019

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 .

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