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

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.

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).

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