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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • Functional Resistance Training
  • Stretching
  • Delayed Functional Resistance Training

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Oregon Health and Science University

Collaborator