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Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength

2020년 12월 10일 업데이트: Karolinska Institutet

Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors

This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. A comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.

All patients within OSCAR are invited to the intervention trial. Half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. The intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. The control group will follow their routine daily physical activity. HRQOL measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. Compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

162

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스웨덴
      • Stockholm, 스웨덴
        • Surgical cares sciences, Karolinksa Institutet

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate

Exclusion Criteria:

  • Current malignancies or co-morbidities, psychological or social conditions that prevent participation
  • Patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Physical activity intervention group
The physical activity program includes 150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week are demonstrated by the research nurse. The resistance training is progressive by increasing resistance in the band based on patient's adaptability during the intervention.
행동: Physical activity intervention group
150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week.
간섭 없음: Standard care control group
Patients follow their routine daily physical activity.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
기간: At baseline and after the 12 weeks intervention/control programme.
The main outcome measure will be increase in skeletal muscle mass using a bio-impedance analysis portable monitor. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
At baseline and after the 12 weeks intervention/control programme.
Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
기간: At baseline and after the 12 weeks intervention/control programme.
The main outcome measure will be increase in skeletal muscle strength using a handgrip dynamometer and 30 second sit stand test. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
At baseline and after the 12 weeks intervention/control programme.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants with improvement in physical function scale of health related quality of life as assessed from the questionnaire - European Organization for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) - C30.
기간: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the physical function scale of HRQOL using EORTC QLQ-C30 questionnaires before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
기간: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the fatigue scale of HRQOL using EORTC fatigue questionnaire QLQ-FA13 before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in appetite loss function of health related quality of life as assessed from the oesophageal disease specific module - EORTC QLQ-OG25.
기간: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the appetite loss function of HRQOL using EORTC QLQ-OG25 questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in eating difficulties scale of health related quality of life as assessed from the cachexia module of EORTC - QLQ-CAX24.
기간: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the eating difficulties scale of HRQOL using EORTC QLQ-CAX24 questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
기간: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the psychosocial issues using HADS questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
기간: At baseline and after the 12 weeks intervention/control programme.
This secondary outcome shall include changes in the total physical activity level measured using the international physical activity questionnaire (IPAQ) before and after the intervention.
At baseline and after the 12 weeks intervention/control programme.
Number of participants with improvement in dietary intake measured using 3 day food diary.
기간: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
This secondary outcome shall include changes in dietary intake measured using food dairy measured thrice a week: two weekdays and 1 weekend day before and after the intervention.
Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Karolinska Institutet

수사관

  • 수석 연구원: Pernilla Lagergren, Professor, Karolinska Institutet

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 1월 1일

기본 완료 (실제)

2020년 6월 1일

연구 완료 (실제)

2020년 6월 1일

연구 등록 날짜

최초 제출

2016년 4월 28일

QC 기준을 충족하는 최초 제출

2016년 5월 16일

처음 게시됨 (추정)

2016년 5월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 12월 10일

마지막으로 확인됨

2020년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • PA study

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

식도암에 대한 임상 시험

Physical activity intervention group에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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