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Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial

2026년 4월 27일 업데이트: Eduardo Lusa Cadore, Federal University of Rio Grande do Sul

Effects of a Multicomponent Exercise Program on Functional Capacity, Neuromuscular Parameters, Quality of Life, and Disease-Related Symptoms in Older Adults Undergoing Cancer Treatment: A Randomized, Controlled Clinical Trial

This study aims to understand how a home-based exercise program can help improve strength, mobility, and quality of life in older adults receiving cancer treatment.

Participants will be randomly divided into two groups:

One group will follow a one-year multicomponent exercise program based on the ViviFrail model, done safely at home.

The other group will continue with usual care.

We will include men and women aged 60 or older treated at Hospital Conceição in Porto Alegre. Assessments will take place at the beginning and after 12, 24, and 48 weeks.

We will measure walking speed, balance, muscle strength, and ask about quality of life, symptoms, and daily activity.

The goal is to see whether home-based exercise can help older adults with cancer stay stronger, more independent, and feel better during treatment.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

The main objective of this study is to identify and compare the effects of a one-year physical exercise program based on the ViviFrail model versus usual care on functional capacity, neuromuscular parameters, quality of life, and disease-related symptoms in older adults undergoing cancer treatment.

연구 유형

중재적

등록 (추정된)

180

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

  • 브라질
      • Porto Alegre, 브라질, 91350-200
        • 모병
        • Hospital Conceição
        • 연락하다:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90690-200
        • 아직 모집하지 않음
        • Escola de Educação Física Fisioterapia e Dança - UFRGS
        • 연락하다:

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria: Men and women aged 60 years or older who are undergoing cancer treatment at Hospital Conceição in Porto Alegre, who have the cognitive ability to understand the exercises, are able to walk (even with assistance), and have medical clearance to participate in physical exercise will be included in the study.

-

Exclusion Criteria: Participants who miss more than two assessments will be excluded.

-

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Multicomponent Training
Multicomponent exercise
행동: Multicomponent exercise
Participants randomized to the intervention group will receive educational material about exercising during cancer treatment. In addition, they will receive a physical exercise passport based on the ViviFrail program (A, B, C, or D) according to their baseline assessment. The passport includes instructions and illustrations of each exercise, as well as details on the number of sets and repetitions, required equipment, and a training log. Furthermore, participants in the intervention group will have access to online materials, including videos demonstrating each exercise, and will attend a pre-scheduled in-person session at Hospital Conceição in Porto Alegre to address any questions.
간섭 없음: Control
Patients randomized to the control group will receive general health guidance and instructions to continue with their usual care. To monitor participants in both groups over time, monthly contacts will be made via phone or messaging app.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Gait ability
기간: From enrollment and at 4, 12, 24 and 48 weeks
Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
From enrollment and at 4, 12, 24 and 48 weeks
Hand grip strength
기간: From enrollment and at 4, 12, 24 and 48 weeks
Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015).
From enrollment and at 4, 12, 24 and 48 weeks
SPPB Battery
기간: From enrollment and at 4, 12, 24 and 48 weeks
SPPB tests: the five-times sit-to-stand test from a standard chair, 4-meter gait speed test, and balance tests in bipodal, semi-tandem, and tandem positions. (Izquierdo, 2019)
From enrollment and at 4, 12, 24 and 48 weeks
Peak power on seat to standing movement
기간: From enrollment and at 4, 12, 24 and 48 weeks
using a linear displacement transducer (encoder) during the three-times sit-to-stand test from a standard chair. The participant will start seated, with their hands resting on their knees, and the encoder will be attached to the right wrist using a Velcro strap. At the command "go," the participant will be instructed to stand up from the chair as quickly as possible and sit back down, repeating the movement three times.
From enrollment and at 4, 12, 24 and 48 weeks
number of hospitalizations
기간: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
From enrollment and at the end of the study, in 48 weeks
Treatment toxicity
기간: From enrollment and at the end of the study, in 48 weeks
NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022).
From enrollment and at the end of the study, in 48 weeks
Mortality rate
기간: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
From enrollment and at the end of the study, in 48 weeks
Number of falls
기간: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
From enrollment and at 4, 12, 24 and 48 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Physical activity level
기간: From enrollment and at the end of the study, in 48 weeks
Physical activity level will be assessed using the Baecke Physical Activity Questionnaire (Simões, 2009), which refers to the 12 months prior to the study and is divided into questions related to daily living activities, sports activities, and leisure activities. Participants will be classified as low physical activity (≤ 9.11 points), moderately active (9.12 to 16.17 points), or highly active (≥ 16.18 points).
From enrollment and at the end of the study, in 48 weeks
Vastus lateralis muscle thickness
기간: From enrollment and at 4, 12, 24 and 48 weeks
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus lateralis of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus lateralis will be collected at 30% of the distance from the lateral femoral epicondyle to the greater trochanter, along the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
From enrollment and at 4, 12, 24 and 48 weeks
Vastus intermedius muscle thickness
기간: From enrollment and at 4, 12, 24 and 48 weeks
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus intermedius of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
From enrollment and at 4, 12, 24 and 48 weeks
Rectus femoralis muscle thickness
기간: From enrollment and at 4, 12, 24 and 48 weeks
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the rectus femoralis of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
From enrollment and at 4, 12, 24 and 48 weeks
Quality of Life Questionnarie
기간: From enrollment and at 4, 12, 24 and 48 weeks
Will be assessed using the Nottingham Health Profile (NHP), which contains 38 items related to overall quality of life and produces a score ranging from 0 (best quality of life) to 38 (worst quality of life) (Teixeira-Salmela et al., 2004).
From enrollment and at 4, 12, 24 and 48 weeks
Fatigue related symptons
기간: From enrollment and at 4, 12, 24 and 48 weeks
Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
From enrollment and at 4, 12, 24 and 48 weeks
Sleep quality
기간: From enrollment and at 4, 12, 24 and 48 weeks
Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)
From enrollment and at 4, 12, 24 and 48 weeks
Disease prognosis
기간: From enrollment and at 4, 12, 24 and 48 weeks
Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
From enrollment and at 4, 12, 24 and 48 weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Sociodemographic characteristics
기간: At the enrollment
Standardized questionnaire
At the enrollment
Comorbidities
기간: At the enrollment
Standardized questionnaire
At the enrollment
Stage of the tumor
기간: At the enrollment
Standardized questionnaire
At the enrollment
Type of tumor
기간: At the enrollment
Standardized questionnaire
At the enrollment
Adherence to the exercise program
기간: After 4, 12, 24 and 48 weeks of intervention
Exercise adherence will be assessed through monitoring of training logs.
After 4, 12, 24 and 48 weeks of intervention
Total body mass
기간: From enrollment and at the end of the study, in 48 weeks
Will be measured using a digital scale
From enrollment and at the end of the study, in 48 weeks
Body height
기간: From enrollment and at the end of the study, at 48 weeks
Will be measured using a measuring tape with 1 mm resolution.
From enrollment and at the end of the study, at 48 weeks
Waist circunference
기간: From enrollment and at the end of the study, at 48 weeks
Will be measured using a measuring tape with 1 mm resolution.
From enrollment and at the end of the study, at 48 weeks
Nutritional assessment
기간: From enrollment and at the end of the study, at 48 weeks
Nutritional status will be evaluated using a three-day dietary recall.
From enrollment and at the end of the study, at 48 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Federal University of Rio Grande do Sul

수사관

  • 수석 연구원: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul

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)

2026년 3월 2일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 4월 27일

QC 기준을 충족하는 최초 제출

2026년 4월 27일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 27일

마지막으로 확인됨

2025년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • URioGrandeCancer

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Data will be provided only upon request, after the study is completed and published in a scientific journal.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

암에 대한 임상 시험

Multicomponent exercise에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Saudi Arabia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다