Phase I Randomized Controlled Trial of Functional Resistance Training in Older Cancer Survivors: The ACES Trial (ACES)
2026년 5월 21일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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).
연구 유형
중재적
등록 (추정된)
150
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU Knight Cancer Institute
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연락하다:
- Kerri Winters-Stone, Ph.D.
- 전화번호: 503-494-0813
- 이메일: wintersk@ohsu.edu
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수석 연구원:
- Kerri Winters-Stone, Ph.D.
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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
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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다른: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Loss-to-Follow Up
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed Up and Go (TUG) test
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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]
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frailty
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kerri Winters-Stone, Ph.D., OHSU Knight Cancer Institute
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 (추정된)
2026년 5월 18일
기본 완료 (추정된)
2028년 8월 31일
연구 완료 (추정된)
2028년 8월 31일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 21일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 21일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00028387 (기타 식별자: OHSU Knight Cancer Institute)
- 4R33CA280996-03 (미국 NIH 보조금/계약)
- NCI-2025-02748 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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. .