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Hematopoietic and Lymphatic System NeoplasmACESNCT07606313

Phase I Randomized Controlled Trial of Functional Resistance Training in Older Cancer Survivors: The ACES Trial

A study testing Functional Resistance Training, Stretching and Delayed Functional Resistance Training in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Functional Resistance Training, Stretching and Delayed Functional Resistance Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteUnited States
Study dates
18 May 2026to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Kerri Winters-Stone, Ph.D., 503-494-0813, wintersk@ohsu.edu

    Kerri Winters-Stone, Ph.D.

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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).

Being tested
Functional Resistance Training, Stretching, Delayed Functional Resistance Training
Keywords
Cancer, Exercise, Cancer survivor, Functional limitation, Clinical trial, Older adult, Feasibility
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Resistance TrainingOther

    Also called Strength Training, Exercise, Progressive Functional Resistance Training (PFRT)

    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.

  • StretchingOther

    Also called Functional Mobility

    Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.

  • Delayed Functional Resistance TrainingOther

    Also called Waitlist Control

    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.

Study groups in NCT07606313
Study groupRoleWhat they receive
Arm I (IMMEDIATE functional resistance training program)ExperimentalParticipants 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.
Receives: Other: Functional Resistance Training
Arm II (IMMEDIATE stretching program)Placebo comparatorParticipants 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.
Receives: Other: Stretching
Arm III (DELAYED functional resistance training program)OtherParticipants 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.
Receives: Other: Delayed Functional Resistance Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loss-to-Follow Up

    Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing.

    Measured: 16 weeks

  2. Permanent Discontinuation

    Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit.

    Measured: 16 weeks

  3. Attendance

    Measured by the percentage of prescribed online sessions attended over the intervention period

    Measured: 16 weeks

  4. Treatment Interruption

    Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period

    Measured: 16 weeks

  5. Dose Modification

    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

    Measured: 16 weeks

  6. Pre-treatment Dose Modification

    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

    Measured: 16 weeks

  7. Tolerability (Relative Dose Intensity)

    Measured by the cumulative dose of training received divided by the cumulative dose of prescribed training, expressed as a percentage over the intervention period

    Measured: 16 weeks

Secondary outcomes (16)
  1. Timed Up and Go (TUG) test

    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

    Measured: Baseline, 16 weeks

  2. Physical Performance Battery (PPB) test

    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.

    Measured: Baseline, 16 weeks

  3. Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a

    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.

    Measured: Baseline, 16 weeks

  4. PROMIS Sleep Disturbance Short Form 8a

    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.

    Measured: Baseline, 16 weeks

  5. PROMIS Depression Short Form 4a

    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.

    Measured: Baseline, 16 weeks

  6. PROMIS Physical Function Short Form 10a

    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.

    Measured: Baseline, 16 weeks

  7. PROMIS Pain Intensity Short Form 10a

    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.

    Measured: Baseline, 16 weeks

  8. PROMIS Cognition Short Form 8a

    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.

    Measured: Baseline, 16 weeks

  9. PROMIS Anxiety Short Form 4a

    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.

    Measured: Baseline, 16 weeks

  10. EuroQoL-5 Dimensions (EQ-5D) Questionnaire

    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.

    Measured: Baseline, 16 weeks

  11. European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQC-30)

    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.

    Measured: Baseline, 16 weeks

  12. Nottingham Scale for Extended Activities of Daily Living (NEADL)

    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.

    Measured: Baseline, 16 weeks

  13. Life Space Questionnaire (LSQ)

    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.

    Measured: Baseline, 16 weeks

  14. Late Life Function and Disability instrument (LLFDI)

    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.

    Measured: Baseline, 16 weeks

  15. Montreal Cognitive Assessment (MoCA)

    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.

    Measured: Baseline, 16 weeks

  16. Adverse Event Prevalence and Attribution [Safety]

    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.

    Measured: Monthly over the 16-week intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start18 May 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three-arm, parallel group, randomized clinical trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606313
Sponsor's protocol ID
STUDY00028387
Other IDs
4R33CA280996-03, NCI-2025-02748, STUDY00028387
Acronym
ACES
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
26 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional Resistance Training, Stretching and Delayed Functional Resistance Training in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loss-to-Follow Up (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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