The COACH Project: Combined Online Assistance for Caregiver Health

Not Applicable

• Conditions: Traumas, Brain; Concussion, Brain; Alzheimer Disease; Head Injury; TBI; Dementia
• Interventions: Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training; Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training

• Registration Number: NCT03123224
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. individuals aged 18 - 85
2. distress associated with being the primary caregiver of a person with TBI or dementia
3. endorsement of at least two of the following items: felt overwhelmed, felt like needed to cry, angry or frustrated, distant or cut of from family or friends, moderate to high levels of stress, felt their health had declined
4. provide at least one hour of care (supervision or direct assistance) per week over the past three months
5. approval by Primary Care Provider to participate in physical exercise
6. be proficient in spoken and written English

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Exclusion Criteria

1. current or lifetime history of any psychiatric disorder with psychotic features
2. prominent suicidal or homicidal ideation
3. current alcohol or substance abuse
4. diagnosis of probable or possible dementia
5. a Short Portable Mental Status score of ≥ 8
6. participation in another caregiver intervention within the past year
7. lack of regular access to the internet
8. planned transfer of care recipient to another caregiver or nursing home within 12 months; 8) current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate >85 beats/min, or 24 hour maximal ventricular rate >150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia >3 beats in succession, or 24 hour PVC count >20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction < 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
9. inability to participate in an exercise stress test
10. morbid obesity (BMI > 39)
11. inability to read, verbalize understanding and voluntarily sign the Informed Consent.

Caregivers meeting any of these exclusion criteria will be excluded from all aspects of this project.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Aerobic and Resistance Exercise	Combined Aerobic and Resistance Exercise + Caregiver Skills Training	Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. Exercises will focus on increasing the heart rate to a point at which participants will breathe more heavily and may sweat.
Balance and Flexibility	Stretching Balance and Flexibility + Caregiver Skills Training	Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.

Primary Outcome Measures

Name	Time	Method
Caregiver Burden using Zarit Burden Inventory	Six Months	Zarit Burden Inventory

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States