Fitness, Cellular Aging, and Caregiver Stress Study

NCT01993082 | Completed

• 1 other identifier: R00HL109247-03
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Stress; Disease Risk

Keywords

Caregivers; Telomerase; Telomere Length; Psychological Stress; Cardiovascular Risk; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Telomerase in Peripheral Blood Mononuclear Cells

  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.

  Measured at Week 0 (baseline) and Week 24

Secondary Outcomes (7)

• Change in Cardiovascular Fitness

  Measured at Week 0 (baseline) and Week 24

• Change in Diastolic and Systolic Blood Pressure

  Measured at Week 0 (baseline) and Week 24

• Change in Psychological Well-being (general and daily)

  Measured at Week 0 (baseline) and Week 24

• Change in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells

  Measured at Week 0 (baseline) and Week 24

• Change in Mitochondrial Functioning (Enzyme Activity, DNA Copy Number) in Peripheral Blood Mononuclear Cells

  Measured at Week 0 (baseline) and Week 24

Study Arms (2)

Aerobic Training Intervention

EXPERIMENTAL

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.

Behavioral: Aerobic Training Intervention

Activity Maintenance Group

NO INTERVENTION

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.

Interventions

Aerobic Training Intervention BEHAVIORAL

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.

Aerobic Training Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Samantha Schilf, BA

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

US (1)