Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
2026年4月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Eduardo L Cadore, PhD
- 電話番号：+555191193651
- メール：edcadore@yahoo.com.br
研究場所
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Porto Alegre、ブラジル、91350-200
- 募集
- Hospital Conceição
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コンタクト：
- Eduarda Blanco Rambo, Me
- 電話番号：5551999079773
- メール：eduardarambo@gmail.com
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90690-200
- まだ募集していません
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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コンタクト：
- Eduardo L Cadore, PhD
- 電話番号：+555191193651
- メール：edcadore@yahoo.com.br
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
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Exclusion Criteria: Participants who miss more than two assessments will be excluded.
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研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Multicomponent Training
Multicomponent exercise
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gait ability
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
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From enrollment and at 4, 12, 24 and 48 weeks
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Hand grip strength
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015).
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From enrollment and at 4, 12, 24 and 48 weeks
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SPPB Battery
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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)
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From enrollment and at 4, 12, 24 and 48 weeks
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Peak power on seat to standing movement
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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.
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From enrollment and at 4, 12, 24 and 48 weeks
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number of hospitalizations
時間枠：From enrollment and at the end of the study, in 48 weeks
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Standardized questionnaire
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From enrollment and at the end of the study, in 48 weeks
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Treatment toxicity
時間枠：From enrollment and at the end of the study, in 48 weeks
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NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022).
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From enrollment and at the end of the study, in 48 weeks
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Mortality rate
時間枠：From enrollment and at the end of the study, in 48 weeks
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Standardized questionnaire
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From enrollment and at the end of the study, in 48 weeks
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Number of falls
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Standardized questionnaire
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From enrollment and at 4, 12, 24 and 48 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical activity level
時間枠：From enrollment and at the end of the study, in 48 weeks
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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).
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From enrollment and at the end of the study, in 48 weeks
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Vastus lateralis muscle thickness
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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.
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From enrollment and at 4, 12, 24 and 48 weeks
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Vastus intermedius muscle thickness
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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.
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From enrollment and at 4, 12, 24 and 48 weeks
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Rectus femoralis muscle thickness
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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.
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From enrollment and at 4, 12, 24 and 48 weeks
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Quality of Life Questionnarie
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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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).
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From enrollment and at 4, 12, 24 and 48 weeks
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Fatigue related symptons
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
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From enrollment and at 4, 12, 24 and 48 weeks
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Sleep quality
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)
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From enrollment and at 4, 12, 24 and 48 weeks
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Disease prognosis
時間枠：From enrollment and at 4, 12, 24 and 48 weeks
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Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
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From enrollment and at 4, 12, 24 and 48 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sociodemographic characteristics
時間枠：At the enrollment
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Standardized questionnaire
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At the enrollment
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Comorbidities
時間枠：At the enrollment
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Standardized questionnaire
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At the enrollment
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Stage of the tumor
時間枠：At the enrollment
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Standardized questionnaire
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At the enrollment
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Type of tumor
時間枠：At the enrollment
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Standardized questionnaire
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At the enrollment
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Adherence to the exercise program
時間枠：After 4, 12, 24 and 48 weeks of intervention
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Exercise adherence will be assessed through monitoring of training logs.
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After 4, 12, 24 and 48 weeks of intervention
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Total body mass
時間枠：From enrollment and at the end of the study, in 48 weeks
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Will be measured using a digital scale
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From enrollment and at the end of the study, in 48 weeks
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Body height
時間枠：From enrollment and at the end of the study, at 48 weeks
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Will be measured using a measuring tape with 1 mm resolution.
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From enrollment and at the end of the study, at 48 weeks
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Waist circunference
時間枠：From enrollment and at the end of the study, at 48 weeks
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Will be measured using a measuring tape with 1 mm resolution.
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From enrollment and at the end of the study, at 48 weeks
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Nutritional assessment
時間枠：From enrollment and at the end of the study, at 48 weeks
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Nutritional status will be evaluated using a three-day dietary recall.
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From enrollment and at the end of the study, at 48 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Eduardo L Cadore, PhD、Federal University of Rio Grande do Sul
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月2日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年4月27日
QC基準を満たした最初の提出物
2026年4月27日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月27日
最終確認日
2025年10月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Data will be provided only upon request, after the study is completed and published in a scientific journal.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。