Phase I Randomized Controlled Trial of Functional Resistance Training in Older Cancer Survivors: The ACES Trial (ACES)
2026年5月21日 更新者：Kerri Winters、OHSU Knight Cancer Institute
ACES: Advancing Capacity to Integrate Exercise Into the Care of Older Cancer Survivors
The study will assess the feasibility and preliminary efficacy of live, online supervised group functional resistance training in older cancer survivors who may have difficulty with independent functioning.
The study design is a three-arm parallel group randomized controlled trial (immediate resistance training, delayed resistance training, stretching placebo) in 150 older cancer survivors.
The resistance training program will be compared to two different types of common control groups: a stretching placebo group and a delayed intervention group.
By using two control conditions, this study can also inform the design of future randomized trials on the selection of an appropriate control group.
調査の概要
状態
まだ募集していません
条件
詳細な説明
This study is designed to begin addressing the current gap in evidence-based exercise guidelines for older cancer survivors, many of whom are at risk for losing their functional independence.
This study is a three-arm parallel group randomized feasibility trial of 16 weeks of live, online supervised group functional resistance training in older (age 65+) cancer survivors (stages I - IV, including hematological malignancies) with or at risk for a functional limitation (n=150).
Participants will be randomized in a 1:1:1 ratio to one of three study arms (immediate progressive functional resistance training (PFRT) intervention, stretching placebo; or, delayed PFRT), stratified by disease stage (metastatic vs non-metastatic).
For both the immediate PFRT arm and the stretching placebo, participants will attend three 45-minute live, online supervised group sessions per week for 16 weeks.
The immediate PFRT arm progresses from low to moderate intensity over 16 weeks based on participant tolerance.
The stretching arm will perform stretches seated in a chair and will emphasize whole body range of motion and relaxation.
The delayed PFRT arm will receive educational information about healthy lifestyle behaviors and monthly check-in calls over the first 16 weeks, then will follow the same exercise protocol as the immediate PFRT arm for an additional 16 weeks, during which feasibility outcomes will be collected.
All participants will undergo two assessments (baseline and post-intervention at 16 weeks), consisting of surveys and performance assessments.
The primary objective is to evaluate acceptability, tolerability, and safety of live, online supervised group functional resistance training sessions, as assessed by loss-to-follow-up, permanent discontinuation (i.e., study withdrawal), attendance to exercise sessions, treatment interruption, exercise dose modification, pre-treatment dose modification, tolerability (i.e., relative dose intensity), and prevalence and attribution status of adverse events.
The secondary objective is to assess preliminary effects of the intervention on physical and mental health outcomes, including objectively measured physical function (Timed Up and Go, Physical Performance Battery), patient-reported symptoms and health related quality of life (Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue, Sleep Disturbance, Depression, Physical Function, Pain Intensity, Cognition, Anxiety; EuroQoL-5 Dimensions, European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30), functional independence and disability (Nottingham Extended Activities of Daily Living, Late-Life Function and Disability Instrument), life-space mobility (Life Space Assessment), cognitive screening (Montreal Cognitive Assessment), frailty indicators (Chair Stand Test, 4-Meter Walk Test, self-reported physical activity and fatigue, and unintentional weight loss), and physical activity behaviors (Community Healthy Activities Model Program for Seniors).
研究の種類
介入
入学 (推定)
150
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。
研究場所
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Oregon
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Portland、Oregon、アメリカ、97239
- OHSU Knight Cancer Institute
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コンタクト：
- Kerri Winters-Stone, Ph.D.
- 電話番号：503-494-0813
- メール：wintersk@ohsu.edu
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主任研究者：
- Kerri Winters-Stone, Ph.D.
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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
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 65 years of age or older
- Diagnosed with stage I-IV cancer =< 5 years ago
- Completed surgery, chemotherapy, or radiation therapy > 3 months ago (concurrent maintenance therapy, such as hormone therapy for breast or prostate cancer, is permissible)
- Self-report at least one limitation in Activities of Daily Living (ADLs) OR at clinical risk of developing ADL impairment as evidenced by a 3-meter timed-up-and-go time > 13.5 seconds or 5-time chair stand time > 12 seconds
- Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed
- Currently underactive (an average of < 30 minutes of moderate-vigorous intensity exercise 3 days/week over the past four weeks)
- Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions
- Home internet sufficient for videoconferencing
Exclusion Criteria:
- Contraindication to moderate intensity exercise
- Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise
- Cognitive impairment consistent with moderate dementia (confirmed by a Montreal Cognitive Assessment (MoCA) score < 14). Cognitive impairment consistent with early-stage dementia (a MoCA score of <20) unless a research partner (e.g., family member, caregiver, close friend) can also be consented and can assist in answering the survey questions, participating in the performance tests, or giving informed consent.
- Not fluent in English and therefore incapable of answering survey questions, following directions during exercise or performance testing, and providing informed consent in English
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：支持療法
- 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：Arm I (IMMEDIATE functional resistance training program)
Participants join a live, online supervised group functional resistance training session, three times per week, over 45 minutes, for 16 weeks.
Participants will receive exercise equipment delivered to their home and perform functional exercises that correspond to movement patterns used in everyday activities (Chair Stand, Lateral walk, Step-up, Heel-toe Raise, Plank, Push-up, 1-arm row with chair, single-arm Bicep Curl, and single-arm Tricep Extension).
The 16-week program is a progressive, low-to-moderate intensity training program with a planned progression that increases the volume of training (intensity and duration (sets and reps)) gradually over time, beginning with a low volume of training.
Exercise dose can be modified per the participants' tolerance to each individual exercise, and participants will be monitored throughout the trial for this purpose.
Caregivers may be present for participants that require additional assistance.
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Participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks.
他の名前：
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プラセボコンパレーター：Arm II (IMMEDIATE stretching program)
Participants join a live, online supervised group stretching and relaxation training session for 45 minutes, three times per week, for 16 weeks.
During the stretching class, participants will perform a series of whole-body flexibility and mobility exercises with a final 15-minute relaxation period (i.e., progressive neuromuscular relaxation, focused breathing).
Stretching exercises will be performed according to the ACSM guidelines for flexibility exercise, and from a seated position in order to minimize weight-bearing forces that might increase muscle strength or mass, and to better accommodate participants who may be unable to get down to and up from the floor.
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Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.
他の名前：
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他の：Arm III (DELAYED functional resistance training program)
Participants do not participate in a group exercise class for 16 weeks and will instead be provided with basic educational information about healthy lifestyle behaviors, and monthly check-in calls from study staff.
After 16 weeks, they will be invited to participate in the same 16-week functional resistance training program as Arm I.
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Participants will receive educational information about healthy lifestyle behaviors and receive monthly check in calls from study staff.
After 16 weeks, participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks.
他の名前：
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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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Loss-to-Follow Up
時間枠：16 weeks
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Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing.
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16 weeks
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Permanent Discontinuation
時間枠：16 weeks
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Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit.
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16 weeks
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Attendance
時間枠：16 weeks
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Measured by the percentage of prescribed online sessions attended over the intervention period
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16 weeks
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Treatment Interruption
時間枠：16 weeks
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Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period
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16 weeks
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Dose Modification
時間枠：16 weeks
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Measured by the number of sessions requiring reduction or escalation in intensity and/or duration (sets or repetitions) after the session begins over the intervention period
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16 weeks
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Pre-treatment Dose Modification
時間枠：16 weeks
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Measured by the number of times a session dose (intensity and/or duration) is reduced or escalated prior to the beginning of a session over the intervention period
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16 weeks
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Tolerability (Relative Dose Intensity)
時間枠：16 weeks
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Measured by the cumulative dose of training received divided by the cumulative dose of prescribed training, expressed as a percentage over the intervention period
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16 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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Timed Up and Go (TUG) test
時間枠：Baseline, 16 weeks
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Physical assessment of mobility by evaluating the time that it takes a person to rise from a chair, walk 3 meters, turn around, and return and sit in the chair.
Faster times indicate better mobility
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Baseline, 16 weeks
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Physical Performance Battery (PPB) test
時間枠：Baseline, 16 weeks
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Physical assessment of three timed tests (five repeated chair stands, standing balance, and usual pace gait speed over 4 meters), scored on a scale of 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed, where higher scores indicate better physical functioning.
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Baseline, 16 weeks
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Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a
時間枠：Baseline, 16 weeks
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Self-report on 13 questions about fatigue in the past seven days, on a scale ranging from 1 (not at all) to 5 (very much), where higher total scores indicate more fatigue.
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Baseline, 16 weeks
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PROMIS Sleep Disturbance Short Form 8a
時間枠：Baseline, 16 weeks
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Self-report on 8 questions about symptoms of sleep disturbance in the past seven days, on a scale ranging from 1 (not at all) to 5 (very much), where higher total scores indicate greater sleep disturbance.
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Baseline, 16 weeks
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PROMIS Depression Short Form 4a
時間枠：Baseline, 16 weeks
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Self-report on 4 questions on depressive symptoms in the past seven days, on a scale ranging from 1 (never) to 5 (always), where higher total scores indicate greater depressive symptoms.
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Baseline, 16 weeks
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PROMIS Physical Function Short Form 10a
時間枠：Baseline, 16 weeks
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Self-report on 10 questions of physical capability and instrumental activities of daily living, on a scale from 1 (unable to do) to 5 (without any difficulty), where higher scores indicate greater physical function.
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Baseline, 16 weeks
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PROMIS Pain Intensity Short Form 10a
時間枠：Baseline, 16 weeks
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Self-report on 3 questions about pain intensity over the past seven days, and current pain intensity, on a scale from 1 (had no pain) to 5 (very severe), where higher scores indicate greater pain intensity.
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Baseline, 16 weeks
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PROMIS Cognition Short Form 8a
時間枠：Baseline, 16 weeks
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Self-report on 8 questions about perceived cognitive function (i.e., memory, concentration, verbal fluency, and mental acuity) over the past seven days, on a scale from 1 (very often [several times a day]) to 5 (never), where higher scores indicate better cognitive function.
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Baseline, 16 weeks
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PROMIS Anxiety Short Form 4a
時間枠：Baseline, 16 weeks
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Self-report on 4 questions about fear, anxious misery, hyperarousal, and somatic symptoms related to arousal, on a scale from 1 (never) to 5 (always), where higher scores indicate worse anxiety-related symptoms.
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Baseline, 16 weeks
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EuroQoL-5 Dimensions (EQ-5D) Questionnaire
時間枠：Baseline, 16 weeks
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Self-report on health-related quality of life, with two components.
1) Five dimensions related to health (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is assigned a level from 1 (no problems) to 5 (extreme problems) and organized into a five-digit number representing the respondent's health state (e.g., 11235).
Each 5-digit number corresponds to a health profile.
2) A visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health), where higher scores indicate better self-perceived health status.
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Baseline, 16 weeks
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European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQC-30)
時間枠：Baseline, 16 weeks
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Self-report on 30 questions about cancer-specific quality of life for five functional scales (physical, cognitive, emotional, social functioning, and role functioning) and one global health scale, on either a 4- (1=not at all to 4=very much) or 7-point (1=very poor to 7=excellent) Likert scale, where higher function-oriented scores indicate better functioning, and higher symptom-oriented scores indicate worse symptom severity.
Transformed scores range from 0-100, where higher scores indicate better functioning.
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Baseline, 16 weeks
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Nottingham Scale for Extended Activities of Daily Living (NEADL)
時間枠：Baseline, 16 weeks
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Self-report on 22 questions about independence in instrumental activities of daily living (IADL; i.e., functional status) over four domains of activity (mobility, leisure, kitchen, and domestic tasks), on a scale from 0 (not at all) to 3 (on my own), where higher scores indicate more independence.
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Baseline, 16 weeks
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Life Space Questionnaire (LSQ)
時間枠：Baseline, 16 weeks
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Self-report on nine questions about movement across different spatial zones (i.e., community mobility) over the preceding three days, scored from 1 (yes) to 0 (no), where higher scores indicate greater mobility.
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Baseline, 16 weeks
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Late Life Function and Disability instrument (LLFDI)
時間枠：Baseline, 16 weeks
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Self-report on 16 questions about physical function and disability in two domains (frequency and limitation).
The frequency scale is from 1 (never) to 5 (very often), where higher scores indicate more frequent participation in social and life activities.
The limitation scale is from 1 (completely) to 5 (not at all), where higher scores indicate less limitations in completing activities.
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Baseline, 16 weeks
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Montreal Cognitive Assessment (MoCA)
時間枠：Baseline, 16 weeks
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Researcher-administered test of 11 questions used to screen for cognitive impairment, on a scale of 0-30 points, where higher scores (26+) indicate normal cognition, and lower scores indicate mild (18-15), moderate (10-17), or severe (<10) cognitive impairment.
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Baseline, 16 weeks
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Adverse Event Prevalence and Attribution [Safety]
時間枠：Monthly over the 16-week intervention period.
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Self-report on adverse events (AE) experienced throughout study involvement, as reported on a monthly AE survey; prevalence, severity, and attribution to the intervention will be determined.
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Monthly over the 16-week intervention period.
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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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Frailty
時間枠：Baseline, 16 weeks
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Self-report and physical testing (five individual assessments) that each represent a component of the Frailty Phenotype. Each assessment either does or does not meet the threshold for frailty (Yes = 1, No = 0) and these are summed to determine the total frailty score (> 3 = frail, 1-2 = pre-frail, 0 = robust). Below is each component, the assessment used, and the threshold that determines the presence of frailty:
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Baseline, 16 weeks
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Community Healthy Activities Model Program for Seniors (CHAMPS)
時間枠：Baseline, 16 weeks
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Self-report on 41 questions about frequency of physical activity over the past four weeks, scored by calculating the frequency (times per week) and estimated caloric expenditure (kcal/week), where higher scores indicate more physical activity.
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Baseline, 16 weeks
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Short Form (SF)-36 Vitality Scale
時間枠：Baseline, 16 weeks
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Self-report on four questions about energy levels and fatigue over the past four weeks, on a scale from 1 (all of the time) to 5 (none of the time), total score is normed (0-100), where higher scores indicate less fatigue (i.e., greater vitality).
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Baseline, 16 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：Kerri Winters-Stone, Ph.D.、OHSU Knight Cancer Institute
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 (推定)
2026年5月18日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月26日
QC基準を満たした最後の更新が送信されました
2026年5月21日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00028387 (その他の識別子：OHSU Knight Cancer Institute)
- 4R33CA280996-03 (米国 NIH グラント/契約)
- NCI-2025-02748 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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。