AgingFASTNCT01993082
Fitness, Cellular Aging, and Caregiver Stress Study
A study testing Aerobic Training Intervention in people with Aging and Stress, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Stress, Disease Risk
- What is being tested?
- Aerobic Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: The Effects of Exercise and Life Stress on Telomere Maintenance and Cardiovascular Disease Risk
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.
Read the 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.
- Conditions
- Aging, Stress, Disease Risk
- Being tested
- Aerobic Training Intervention
- Keywords
- Caregivers, Telomerase, Telomere Length, Psychological Stress, Cardiovascular Risk, Exercise
- Medical subject headings
- Stress, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 0 (baseline) and Week 24
Secondary outcomes (7)
Change in Cardiovascular Fitness
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in Diastolic and Systolic Blood Pressure
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in Psychological Well-being (general and daily)
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in Mitochondrial Functioning (Enzyme Activity, DNA Copy Number) in Peripheral Blood Mononuclear Cells
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in Epigenetic Aging Profiles
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.
Measured: Measured at Week 0 (baseline) and Week 24
Change in mRNA expression
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.
Measured: Measured at Week 0 (baseline) and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Epel, PhD, Principal investigator, University of California, San FranciscoSamantha Schilf, BA, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993082
- Sponsor's protocol ID
- R00HL109247-03
- Acronym
- FAST
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2013
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise and Life Stress on Telomere Maintenance and Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01993082
- Acronym / sponsor ID
- FAST / R00HL109247-03
- Conditions
- Aging, Stress, Disease Risk
- Keywords
- Caregivers, Telomerase, Telomere Length, Psychological Stress, Cardiovascular Risk, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training Intervention | Experimental | Behavioral: Aerobic Training InterventionFor 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. |
| 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Training InterventionFor 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. | Behavioural | Aerobic Training Intervention |
Primary outcome
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.
7 secondary outcomes
Change in Cardiovascular Fitness
Time frame: Measured at Week 0 (baseline) and Week 24
Change in Diastolic and Systolic Blood Pressure
Time frame: Measured at Week 0 (baseline) and Week 24
Change in Psychological Well-being (general and daily)
Time frame: Measured at Week 0 (baseline) and Week 24
Change in Telomere Length in Leukocyte/ Peripheral Blood Mononuclear Cells
Time frame: Measured at Week 0 (baseline) and Week 24
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 in Epigenetic Aging Profiles
Time frame: Measured at Week 0 (baseline) and Week 24
Change in mRNA expression
Time frame: Measured at Week 0 (baseline) and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa Epel, PhD principal investigator
University of California, San Francisco
Samantha Schilf, BA study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training Intervention in people with Aging and Stress, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Telomerase in Peripheral Blood Mononuclear Cells (time frame: Measured at Week 0 (baseline) and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.