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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Gait ability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The person responsible for the randomization will not be one of the researchers involved in the assessments and will have no contact with the participants. Questionnaires and tests will be administered by evaluators blinded to the participants' group allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants who miss more than two assessments will be excluded.
研究组 & 干预措施
Multicomponent Training
Multicomponent exercise
干预措施: Multicomponent exercise (Behavioral)
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.
结局指标
主要结局
Gait ability
时间窗: 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)
Hand grip strength
时间窗: 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).
SPPB Battery
时间窗: 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)
Peak power on seat to standing movement
时间窗: 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.
number of hospitalizations
时间窗: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
Treatment toxicity
时间窗: 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).
Mortality rate
时间窗: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
Number of falls
时间窗: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
次要结局
- Physical activity level(From enrollment and at the end of the study, in 48 weeks)
- Vastus lateralis muscle thickness(From enrollment and at 4, 12, 24 and 48 weeks)
- Vastus intermedius muscle thickness(From enrollment and at 4, 12, 24 and 48 weeks)
- Rectus femoralis muscle thickness(From enrollment and at 4, 12, 24 and 48 weeks)
- Quality of Life Questionnarie(From enrollment and at 4, 12, 24 and 48 weeks)
- Fatigue related symptons(From enrollment and at 4, 12, 24 and 48 weeks)
- Sleep quality(From enrollment and at 4, 12, 24 and 48 weeks)
- Disease prognosis(From enrollment and at 4, 12, 24 and 48 weeks)
研究者
Eduardo Lusa Cadore
Dr
Federal University of Rio Grande do Sul