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.
研究概览
地位
尚未招聘
详细说明
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).
研究类型
介入性
注册 (估计的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Oregon
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Portland、Oregon、美国、97239
- OHSU Knight Cancer Institute
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接触：
- Kerri Winters-Stone, Ph.D.
- 电话号码：503-494-0813
- 邮箱：wintersk@ohsu.edu
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首席研究员：
- Kerri Winters-Stone, Ph.D.
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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安慰剂比较：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.
其他名称：
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其他：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Loss-to-Follow Up
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Timed Up and Go (TUG) test
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：Baseline, 16 weeks
|
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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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]
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frailty
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kerri Winters-Stone, Ph.D.、OHSU Knight Cancer Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月18日
初级完成 (估计的)
2028年8月31日
研究完成 (估计的)
2028年8月31日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月26日
上次提交的符合 QC 标准的更新
2026年5月21日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00028387 (其他标识符：OHSU Knight Cancer Institute)
- 4R33CA280996-03 (美国 NIH 拨款/合同)
- NCI-2025-02748 (注册表标识符：CTRP (Clinical Trial Reporting Program))
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.