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.
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
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
Parallel
Functional Resistance Training
Other interventionParticipants 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.
Stretching
Other interventionParticipants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.
Delayed Functional Resistance Training
Other interventionParticipants 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.
Loss-to-Follow Up
Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing.
Permanent Discontinuation
Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit.
Attendance
Measured by the percentage of prescribed online sessions attended over the intervention period
Treatment Interruption
Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period
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
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.
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.
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.
Frailty
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.
Community Healthy Activities Model Program for Seniors (CHAMPS)
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.
Short Form (SF)-36 Vitality Scale
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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OHSU Knight Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Oregon Health and Science University
Collaborator
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