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

NCT07606313 | Not Yet Recruiting

• 3 other identifiers: STUDY000283874R33CA280996-03NCI-2025-02748
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cancer; Exercise; Cancer survivor; Functional limitation; Clinical trial; Older adult; Feasibility

Outcome Measures

Primary Outcomes (7)

• Loss-to-Follow Up

  Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing.

  16 weeks

• Permanent Discontinuation

  Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit.

  16 weeks

• Attendance

  Measured by the percentage of prescribed online sessions attended over the intervention period

  16 weeks

• Treatment Interruption

  Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period

  16 weeks

• Dose Modification

  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

  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)

  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

Secondary Outcomes (16)

• Timed Up and Go (TUG) test

  Baseline, 16 weeks

• Physical Performance Battery (PPB) test

  Baseline, 16 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a

  Baseline, 16 weeks

• PROMIS Sleep Disturbance Short Form 8a

  Baseline, 16 weeks

• PROMIS Depression Short Form 4a

  Baseline, 16 weeks

Other Outcomes (3)

• Frailty

  Baseline, 16 weeks

• Community Healthy Activities Model Program for Seniors (CHAMPS)

  Baseline, 16 weeks

• Short Form (SF)-36 Vitality Scale

  Baseline, 16 weeks

Study Arms (3)

Arm I (IMMEDIATE functional resistance training program)

EXPERIMENTAL

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.

Other: Functional Resistance Training

Arm II (IMMEDIATE stretching program)

PLACEBO COMPARATOR

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: Stretching

Arm III (DELAYED functional resistance training program)

OTHER

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.

Other: Delayed Functional Resistance Training

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.

Also known as: Strength Training, Exercise, Progressive Functional Resistance Training (PFRT)

Arm I (IMMEDIATE functional resistance training program)

Stretching OTHER

Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.

Also known as: Functional Mobility

Arm II (IMMEDIATE stretching program)

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.

Also known as: Waitlist Control

Arm III (DELAYED functional resistance training program)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerri Winters-Stone, Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion with respect to study arm and categorized based on severity as serious, moderate, or mild, and attribution to the intervention as attributable, possibly attributable, or non-attributable.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm, parallel group, randomized clinical trial.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 26, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)