Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03630354
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2018-08-03
Brief Title:
EXERCISING TOGETHER for Couples Coping With Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
EXERCISING TOGETHER for Couples Coping With Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 spousepartner
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 Couples perform partnered exercise over 1 hour 2 days per week 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
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 spousepartner
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 Couples perform partnered exercise over 1 hour 2 days per week 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA218093 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchR01CA218093 |
| NCI-2018-01404 | REGISTRY | None | None |
| STUDY00018000 | OTHER | None | None |