- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04151238
Exercise Intervention for Cancer Patients
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Turku, 핀란드, 20521
- Turku University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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"
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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physical activity changes in diary
기간: 0 and 8 weeks,
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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)
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0 and 8 weeks,
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questionnaire-feedback from cancer patients
기간: 0 and 8 weeks
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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.
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0 and 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life questionnaire (EORTC QLQ-c30)
기간: 0 and 8 weeks
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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.
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0 and 8 weeks
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Fatigue questionnaire (FACIT-F)
기간: 0 and 8 weeks
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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.
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0 and 8 weeks
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Body composition in cancer patients general view (In-Body-device)
기간: 0 and 8 weeks
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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.
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0 and 8 weeks
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Endurance (submaximal treadmill test)
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in endurance of cancer patients on chemotherapy?
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0 and 8 weeks
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Functional muscle power test - dynamic elevation test for upper arms
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
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0 and 8 weeks
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Functional muscle power test - hand pressure test
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
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0 and 8 weeks
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Functional muscle power test - the lower extremities by repeated squatting-standing
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
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0 and 8 weeks
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Functional muscle power test - the lower extremities by rising to stand on the toes
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
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0 and 8 weeks
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Functional muscle power test - plank-test for the body
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
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0 and 8 weeks
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Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)
기간: 0 and 8 weeks
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Does exercise intervention (physical activity) cause changes in the balance of cancer patients on chemotherapy?
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0 and 8 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- T306/2019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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