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Exercise Intervention for Cancer Patients

1 de novembro de 2022 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

8

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Turku, Finlândia, 20521
        • Turku University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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"

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
physical activity changes in diary
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of life questionnaire (EORTC QLQ-c30)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 0 and 8 weeks
Does exercise intervention (physical activity) cause changes in the balance of cancer patients on chemotherapy?
0 and 8 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de fevereiro de 2020

Conclusão Primária (Real)

16 de abril de 2020

Conclusão do estudo (Real)

8 de maio de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de novembro de 2019

Primeira postagem (Real)

5 de novembro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de novembro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2022

Última verificação

1 de novembro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • T306/2019

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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