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Fitness, Cellular Aging, and Caregiver Stress Study (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993082
Recruitment Status : Unknown
Verified January 2016 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
Change in Telomerase in Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
Change from Baseline in Telomerase in Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Change in Telomerase in Leukocyte/ Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
Change from Baseline in Telomerase in Leukocyte/ Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • Change in Cardiovascular Fitness [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Cardiovascular Fitness at 24 weeks. Participants will participate in fitness testing (treadmill test and respiratory gas analysis/ V02 Peak) at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in Diastolic and Systolic Blood Pressure [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Change in Diastolic and Systolic Blood Pressure at 24 weeks. Study staff will measure blood pressure at participant's baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in Psychological Well-being (general and daily) [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Change in Psychological Well-being (general and daily) at 24 weeks. We will collect perceived stress, caregiving burden, depression measures, emotion regulation, marital satisfaction, rumination, anxiety, self-esteem, and other measures of psychological well-being and distress at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study. We will also have ecological momentary assessments six times a day for one week prior to the intervention and again in the final, 24th, week of the study to examine changes in stress sensitivity as a result of exercise.
  • Change in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study. We will measure telomere length pre- and post-intervention in Leukocyte and Peripheral Blood Mononuclear Cells.
  • Change in Mitochondrial Functioning (Enzyme Activity, DNA Copy Number) in Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Mitochondrial Functioning in Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in Epigenetic Aging Profiles [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Epigenetic Aging Profiles (i.e. Methylation), at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in mRNA expression [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in mRNA expression, at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • Change in Cardiovascular Fitness [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Cardiovascular Fitness at 24 weeks. Participants will participate in fitness testing (treadmill test and respiratory gas analysis/ V02 Peak) at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in Diastolic and Systolic Blood Pressure [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Change in Diastolic and Systolic Blood Pressure at 24 weeks. Study staff will measure blood pressure at participant's baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
  • Change in Psychological Well-being (general and daily) [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Change in Psychological Well-being (general and daily) at 24 weeks. We will collect perceived stress, caregiving burden, depression measures, emotion regulation, marital satisfaction, rumination, anxiety, self-esteem, and other measures of psychological well-being and distress at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study. We will also have ecological momentary assessments six times a day for one week prior to the intervention and again in the final, 24th, week of the study to examine changes in stress sensitivity as a result of exercise.
  • Change in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study. We will measure telomere length pre- and post-intervention in Leukocyte and Peripheral Blood Mononuclear Cells.
  • Change in Mitochondrial Functioning in Leukocyte and Peripheral Blood Mononuclear Cells [ Time Frame: Measured at Week 0 (baseline) and Week 24 ]
    Change from Baseline in Mitochondrial Functioning in Leukocyte and Peripheral Blood Mononuclear Cells at 24 weeks. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 24th week of the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fitness, Cellular Aging, and Caregiver Stress Study
Official Title  ICMJE The Effects of Exercise and Life Stress on Telomere Maintenance and Cardiovascular Disease Risk
Brief Summary The purpose of this study is to determine whether an aerobic training intervention will alter markers of immune cell aging, improve exercise capacity and blood pressure and decrease psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched wait list control caregivers.
Detailed Description

The investigators will prospectively examine whether an aerobic training intervention will alter markers of immune cell aging (i.e. increase telomerase activity in peripheral blood mononuclear cells, telomere length in peripheral blood mononuclear cells and leukocytes, mitochondrial function, epigenetic profiles, and mRNA expression), improve exercise capacity and blood pressure, and decrease psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched wait list control caregivers. Our sample will be comprised of caregivers who provide unpaid care for a family member diagnosed with Alzheimer's disease or other dementia. Participants in the study will be highly stressed and inactive male and female caregivers of family members with Alzheimer's disease or other dementia. All eligible participants will complete one week of ecological momentary assessments (EMA) to examine whether (1) previously unfit, high-stressed caregivers benefit psychologically from becoming active, (2) this benefit is derived through changes in how caregivers react to and recover from stressful events, and (3) whether these salubrious psychological effects mediate changes in biological outcomes (e.g., cellular aging). Next, participants will participate in a one-week run-in period of stretching 30 minutes on 4 separate days prior to randomization to guarantee that the investigators are randomizing well-informed participants that are willing and able to complete the expected exercise. Next, participants are randomized into the aerobic exercise or wait list control arm. In the 24th week of the study, participants complete a second week of the EMAs sub-study, and return after week 24 for a final blood draw.

Research study assessments consist of self-report questionnaires, body composition, physical performance and fitness tests, and a fasting blood draw. The follow-up visit, 24 weeks later, consists of a repeat of the same morning health visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Stress
  • Disease Risk
Intervention  ICMJE Behavioral: Aerobic Training Intervention

For 24 weeks, subjects randomized into the aerobic training group will be asked to increase their physical activity level to meet the Centers for Disease Control and Prevention recommendations for physical activity of 150 minutes per week of moderate activity.

A first visit with a fitness coach support provider, followed by weekly coaching texts and phone calls, will provide the framework for the activities in which participants should engage.

Study Arms  ICMJE
  • Experimental: Aerobic Training Intervention

    For 24 weeks, subjects randomized into the aerobic training group will be asked to increase their physical activity level to meet the Centers for Disease Control and Prevention recommendations for physical activity of 150 minutes per week of moderate activity.

    A first visit with a fitness coach support provider, followed by weekly coaching texts and phone calls, will provide the framework for the activities in which participants should engage.

    Intervention: Behavioral: Aerobic Training Intervention
  • No Intervention: Activity Maintenance Group
    Participants randomized into the waitlist control group receive no aerobic training. Wait-list control participants will receive monthly check-in phone calls to establish that they have not significantly increased activity engagement. Participants in this group will receive a free gym membership at the end of the study, monthly phone calls with a fitness coach support provider for 6 months, and 2 coaching text messages per week.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
110
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 50-75
  • Men and Women (women must be post-menopausal)
  • Body Mass Index must be below 40 (to exclude for extreme obesity, which can confound outcomes)
  • Must be a first or second degree family member providing unpaid caregiving for an adult relative with Alzheimer's disease or other dementias of longer than 6 months since diagnosis.
  • Must report providing care for 10 or more hours per week.
  • Perceived stress ≥ 15 for adults 65 and older; Perceived stress ≥ 18 for adults aged 50-64. (0.5 standard deviation above national average for adults)
  • Do not meet Center for Disease Control recommendations for exercise (150 minutes per week of moderate activity levels or 75 minutes of vigorous)

Exclusion Criteria:

  • Major Chronic Disease that interferes with activity levels as advised by a medical practitioner (Autoimmune disorders; severe asthma; lung disease - emphysema or chronic bronchitis; history of stroke, heart attack, cardiovascular disease, epilepsy, or brain injury)
  • Heart attack in the past 6 months or repeated experience of chest pain or pressure, and/or arrhythmia.
  • Cancer that is not in remission. Those who underwent chemotherapy or radiation within the past 5 years will be excluded.
  • Eating Disorders
  • Current substance dependence that can interfere with activity engagement.
  • Current Post Traumatic Stress Disorder
  • Current or recent smoking status. We will exclude current smokers and past smokers (who quit within the past 5 years).
  • Confounding medications- Oral Steroids containing prescription drugs use and any other drugs that might interfere with the outcome measures.
  • Current major injuries
  • Any physical impairment that prevent participation in moderate levels of physical activity (e.g. musculoskeletal problems, prosthesis)
  • Inability to walk a block or climb stairs without chest pain, losing breath, or dizziness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993082
Other Study ID Numbers  ICMJE R00HL109247-03( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eli Puterman, PhD University of California, San Francisco
Study Director: Samantha Schilf, BA University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP