NCT03630354

EXERCISING TOGETHER for Couples Coping With Cancer

EXERCISING TOGETHER © for Couples Coping With Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The Exercising Together trial is a single-blind, parallel group, randomized controlled trial comparing 3 arms: Arm 1 (experimental): Exercising Together where couples perform partnered exercise in a supervised, group setting versus two comparator conditions where survivors and partners perform exercise routines separately in either a supervised group setting (Arm 2) or unsupervised at home (Arm 3). All three arms will train for a 6-month period and then be followed 6 months later. Data will be collected at baseline, 3, 6 and 12 months.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of Exercising Together on relationship quality (intimacy, communication and incongruence) in couples coping with prostate cancer (PC), breast cancer (BC), or colorectal cancer (CRC). II. Determine the efficacy of Exercising Together on the physical health (body composition, lipids, insulin resistance, blood pressure, inflammation, and physical function) and mental health (anxiety, depressive symptoms, fear of recurrence) of both the survivor and spouse/partner. III. Determine how long individual and couple-level benefits from Exercising Together last. EXPLORATORY OBJECTIVE: I. Identify the types of couples that benefit most from Exercising Together. OUTLINE: Study is a 3-group, 12-month (6 months of exercise training + 6-months follow-up) randomized trial. ARM I: Exercising Together Program: Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting. ARM II: Exercising Together Program: Survivors and spouses/partners perform exercise routines separately in a supervised group setting ARM III: Survivors and partners undergo 2 training sessions over 1 hour with an exercise trainer and then perform exercise routines over 1 hour 2 days per week separately unsupervised at home or a facility following an instructional digital video disc (DVD). The basic training program for all three study arms is a functional strength training program. Participants will use free weights (weighted vest, dumbbells, elastic bands) while performing lower body (chair rises, squats, lunges, stepups) and upper body (1-arm row, bench press, push-ups, triceps extension, bicep curls, shoulder raise) resistance exercise. Volume of resistance exercise, determined by intensity (weight, tailored to each individual) and duration (number of repetitions and sets), is gradually increased from low weight and high repetitions to more weight and fewer repetitions over the training period.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Carcinoma
• Colorectal Carcinoma
• Malignant Solid Neoplasm
• Prostate Carcinoma
• Stage I Colorectal Cancer AJCC v8
• Stage I Prostate Cancer AJCC v8
• Stage II Colorectal Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention (supervised)	Complete supervised exercise
BEHAVIORAL	Exercise Intervention (unsupervised)	Complete unsupervised exercise
OTHER	Informational Intervention	Receive instructional DVD
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-01-18
• Primary completion: 2024-01-01
• Completion: 2024-03-31
• First posted: 2018-08-14
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

1 site across 1 country: United States