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

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • OHSU Knight Cancer Institute
        • Contatto:
          • Kerri Winters-Stone, Ph.D.
          • Numero di telefono: 503-494-0813
          • Email: wintersk@ohsu.edu
        • Investigatore principale:
          • Kerri Winters-Stone, Ph.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Functional Resistance Training
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.
Altri nomi:
  • Esercizio
  • Allenamento della forza
  • Progressive Functional Resistance Training (PFRT)
Comparatore placebo: 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.
Altro: Stretching
Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.
Altri nomi:
  • Mobilità Funzionale
Altro: 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.
Altro: Delayed Functional Resistance Training
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.
Altri nomi:
  • Controllo della lista d'attesa

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Loss-to-Follow Up
Lasso di tempo: 16 weeks
Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing.
16 weeks
Permanent Discontinuation
Lasso di tempo: 16 weeks
Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit.
16 weeks
Attendance
Lasso di tempo: 16 weeks
Measured by the percentage of prescribed online sessions attended over the intervention period
16 weeks
Treatment Interruption
Lasso di tempo: 16 weeks
Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period
16 weeks
Dose Modification
Lasso di tempo: 16 weeks
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
16 weeks
Pre-treatment Dose Modification
Lasso di tempo: 16 weeks
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
16 weeks
Tolerability (Relative Dose Intensity)
Lasso di tempo: 16 weeks
Measured by the cumulative dose of training received divided by the cumulative dose of prescribed training, expressed as a percentage over the intervention period
16 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Timed Up and Go (TUG) test
Lasso di tempo: Baseline, 16 weeks
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
Baseline, 16 weeks
Physical Performance Battery (PPB) test
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Sleep Disturbance Short Form 8a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Depression Short Form 4a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Physical Function Short Form 10a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Pain Intensity Short Form 10a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Cognition Short Form 8a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
PROMIS Anxiety Short Form 4a
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
EuroQoL-5 Dimensions (EQ-5D) Questionnaire
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQC-30)
Lasso di tempo: 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.
Baseline, 16 weeks
Nottingham Scale for Extended Activities of Daily Living (NEADL)
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Life Space Questionnaire (LSQ)
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Late Life Function and Disability instrument (LLFDI)
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Montreal Cognitive Assessment (MoCA)
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Adverse Event Prevalence and Attribution [Safety]
Lasso di tempo: Monthly over the 16-week intervention period.
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.
Monthly over the 16-week intervention period.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Frailty
Lasso di tempo: Baseline, 16 weeks

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:

  1. Weakness (Chair Stand Test, described above in the PPB); >12 seconds.
  2. Slowness (4-Meter Walk Test, described above in the PPB); walking four meters at < 1 meter/second.
  3. Low Activity (self-reported CHAMPS, described below); < 270 kcal/week (female) and < 383 kcal/week (male).
  4. Exhaustion (self-reported fatigue, details described below in the SF-36 Vitality Scale); scores < 40 (normed).
  5. Shrinking (self-reported unintentional weight loss, measured in pounds); >10 pounds lost unintentionally over the prior year.
Baseline, 16 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS)
Lasso di tempo: Baseline, 16 weeks
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.
Baseline, 16 weeks
Short Form (SF)-36 Vitality Scale
Lasso di tempo: Baseline, 16 weeks
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).
Baseline, 16 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

OHSU Knight Cancer Institute

Collaboratori

National Cancer Institute (NCI)
Oregon Health and Science University

Investigatori

  • Investigatore principale: Kerri Winters-Stone, Ph.D., OHSU Knight Cancer Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

18 maggio 2026

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00028387 (Altro identificatore: OHSU Knight Cancer Institute)
  • 4R33CA280996-03 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2025-02748 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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