Recruiting

Observational Study

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT03123224

Conditions

Traumas, Brain

Alzheimer Disease

Dementia

Head Injury

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Combined Aerobic and Resistance Exercise + Caregiver Skills Training

Stretching Balance and Flexibility + Caregiver Skills Training

Study Details

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.

Conditions

Traumas, Brain

Alzheimer Disease

Dementia

Head Injury

Concussion, Brain

Study ID

NCT03123224

Start date

Aug, 2015

Status verified date

Jan, 2018

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined Aerobic and Resistance Exercise

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.

active comparator: Balance and Flexibility

Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.

Interventions

Combined Aerobic and Resistance Exercise + Caregiver Skills Training

The combined moderate to high intensity combined aerobic and resistance exercise training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.

Stretching Balance and Flexibility + Caregiver Skills Training

The stretching, balance and flexibility training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.

Primary outcome measure

  • Caregiver Burden using Zarit Burden Inventory [ Time Frame: Six Months ]

Central Contacts and Locations

Central contacts

Jennifer Fairchild, PhD

650-493-5000

Marisol Hernandez

650-493-5000

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Amerah Hashmi

650-493-5000

Principal Investigator:

Jennifer K Fairchild, PhD

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Jan 18, 2018

Last verified

Jan, 2018

Keywords

  • Caregiver
  • Caregiving
  • TBI
  • dementia
  • Alzheimer's disease
  • physical exercise
  • physical activity
  • psychosocial
  • caregiver skills training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2018-01-18.