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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT07606313
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Functional Limitation
  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Functional Resistance Training — OTHER
    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.
  • Stretching — OTHER
    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 Training — OTHER
    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 Details

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.

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.
  • Other: 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.

Primary Outcome Measure

Loss-to-Follow Up [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Kerri Winters-Stone, Ph.D.
[email protected]
503-494-0813
Kerri Winters-Stone, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
OHSU Knight Cancer Institute· Portland, OR

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