HypertensionACES-PNCT01891513
ACE Inhibitors Combined With Exercise for Seniors - Pilot Study
An observational study of Hypertension and Aging, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Aging
- What is being tested?
- Exercise, ACE inhibitor + exercise and Thiazide diuretic + exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2017
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Aging adults with hypertension and physical limitation within Alachua County
Who may be able to join
- Age 65 years and older
- Hypertension - untreated (Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg) or treated
- Physical limitations evidenced by either:
- Score ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.2 m/sec during 400 m usual-paced test
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
- Willingness to participate in all study procedures
Who cannot join
- Failure to provide informed consent
- Inability to complete 400 m walk within 15 minutes without sitting or interpersonal assistance, as an indicator of disablement and likely inability to fully engage in the exercise intervention
- Primary indication for ACE inhibitor use, i.e. Congestive Heart Failure, CAD, diabetes
- Known hypersensitivity to ACE inhibitors
- Resistant hypertension, defined as BP > 140/90, despite the use of three or more anti-hypertensive drugs
- Office or average home SBP > 180 mm Hg or DBP > 110 mm Hg (Average home BP in any seven day period during trial)
Show all 20Show fewer
- Primary renal disease
- Serum creatinine >2.5 mg/dL in men, or >2.0 mg/dL in women
- Serum potassium >5.0 molar equivalent/L
- Urinary protein > 1 on dipstick
- Abnormal liver enzymes (Aspartate transaminase (AST), Alanine transaminase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal)
- Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Acute myocardial infarction identified by ECG
- Lives in a nursing home (persons living in assisted or independent housing will not be excluded)
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment, which would preclude completion of the assessments and/or intervention
- Other significant co-morbid disease that would prevent participation in exercise
- Planning to move out of the area during the study time frame
- Simultaneous participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
Official title: Multimodal Intervention to Reduce Cardiovascular Risk Among Hypertensive Older Adults
The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.
Read the detailed description
An initial telephone screening will indicate eligibility to participate in the study. The first study visit ("Screening visit") will further determine eligibility to participate. If eligible to fully participate, this study will consist of a structured physical activity program for 24 weeks. In addition, taking daily medication to control your blood pressure and coming to the clinic for several additional assessment visits to monitor your safety and measure study outcomes.
This physical activity program will include moderate-intensity walking, lower-body strengthening, flexibility, and balance training. For the first 12 weeks, of participation there will be three (3) physical activity sessions per week at the physical activity center. These sessions will be led by investigators study staff. These sessions will be used to begin the walking program and to introduce the participant to the strength, stretching, and balance parts of the program in a safe manner. This will allow instructors to better tailor the program to individual needs and abilities. These sessions will involve 40-60 minutes of physical activity instruction. For the final 12 weeks of the intervention, there will be two (2) of these sessions per week.
Participants will also be engage in home-based walking twice per week. This walking can be done at home, community-based physical activity centers (YMCA, senior centers, churches, etc.), or other appropriate facilities as desired. Participants will be asked to report the number of minutes walked each week.
Participants will be randomly assigned to take one of three medications to continue treating blood pressure. These medications are Perindopril, Losartan, and Hydrochlorothiazide. Each medication represents a separate type medication commonly used in practice. These medications are all standard, FDA-approved medications for the treatment of blood pressure. During the time of participating in the study, the use of the normal blood pressure medication will be replaced with the medication assigned during the study. The medications will be inserted into identical capsules by the study pharmacy so that neither participants nor the investigators will know which medication is being used.
Study staff will monitor blood pressure during the study under the supervision of a board-certified cardiologist, and any necessary adjustments to the medication will be indicated by the physician. Participants will also be provided with a blood pressure monitor to use at home during the study and asked to check blood pressure each day and report any abnormal values to study staff. This monitor also automatically records each blood pressure reading. Please bring this monitor to each assessment visit so that study staff can download the stored blood pressure readings.
- Conditions
- Hypertension, Aging
- Being tested
- Exercise, ACE inhibitor + exercise, Thiazide diuretic + exercise, Angiotensin receptor blocker + exercise
- Keywords
- Physical activity, Hypertension, Physical function, Aging
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week.
ACE inhibitor + exerciseDrug
Also called Perindopril
In addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day.
Thiazide diuretic + exerciseDrug
Also called Hydrochlorothiazide
In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day.
Angiotensin receptor blocker + exerciseDrug
Also called Losartan
In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| ACE inhibitor + exercise | In addition to exercise training, participants will receive an initial perindopril dose of 4 mg/day which will be titrated to 8 mg/day. Receives: Behavioral: Exercise; Drug: ACE inhibitor + exercise | |
| Thiazide diuretic + exercise | In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day. Receives: Behavioral: Exercise; Drug: Thiazide diuretic + exercise | |
| Angiotensin receptor blocker + exercise | In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day. Receives: Behavioral: Exercise; Drug: Angiotensin receptor blocker + exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Speed
Investigators will assess walking speed by asking the participants to walk at their usual pace over a 4 m course. Participants will be instructed to stand with both feet touching the starting line and to start walking after a specific verbal command.
Measured: Baseline, 6 months
Secondary outcomes (3)
Change in body composition
Changes in skeletal muscle and adipose tissue (by modulating cardiometabolic function)both fat mass and fat-free mass (FFM) will be assessed using dual energy x-ray absorptiometry (DEXA).
Measured: Baseline, 6 months
Changes in circulating indices of cardiovascular risk
Fasting blood samples (serum or plasma as appropriate) will be evaluated for blood lipids, glucose, and hemoglobin A(1c) levels. Samples will also be used to assay for prominent markers of inflammation (e.g. Tumor necrosis factor-α (TNF-α), Interleukin 6 (IL-6), Vascular cell adhesion protein 1 (VCAM-1), E-selectin) and oxidative stress, including oxidized LDL and myeloperoxidase (MPO).
Measured: Baseline, 6 months
Change in Exercise Capacity
Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test, a safe and reliable test of aerobic endurance in older persons and those with cardiovascular conditions.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Thomas Buford, Ph.D., Principal investigator, University of Florida Department of Aging and Geriatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891513
- Sponsor's protocol ID
- IRB201500525
- Other IDs
- 13SDG17080033, 099-2013
- Acronym
- ACES-P
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2013
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention to Reduce Cardiovascular Risk Among Hypertensive Older Adults
- ClinicalTrials.gov ID
- NCT01891513
- Acronym / sponsor ID
- ACES-P / IRB201500525
- Conditions
- Hypertension, Aging
- Keywords
- Physical activity, Hypertension, Physical function, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Jul 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 compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.
Detailed description
An initial telephone screening will indicate eligibility to participate in the study. The first study visit ("Screening visit") will further determine eligibility to participate. If eligible to fully participate, this study will consist of a structured physical activity program for 24 weeks. In addition, taking daily medication to control your blood pressure and coming to the clinic for several additional assessment visits to monitor your safety and measure study outcomes.
This physical activity program will include moderate-intensity walking, lower-body strengthening, flexibility, and balance training. For the first 12 weeks, of participation there will be three (3) physical activity sessions per week at the physical activity center. These sessions will be led by investigators study staff. These sessions will be used to begin the walking program and to introduce the participant to the strength, stretching, and balance parts of the program in a safe manner. This will allow instructors to better tailor the program to individual needs and abilities. These sessions will involve 40-60 minutes of physical activity instruction. For the final 12 weeks of the intervention, there will be two (2) of these sessions per week.
Participants will also be engage in home-based walking twice per week. This walking can be done at home, community-based physical activity centers (YMCA, senior centers, churches, etc.), or other appropriate facilities as desired. Participants will be asked to report the number of minutes walked each week.
Participants will be randomly assigned to take one of three medications to continue treating blood pressure. These medications are Perindopril, Losartan, and Hydrochlorothiazide. Each medication represents a separate type medication commonly used in practice. These medications are all standard, FDA-approved medications for the treatment of blood pressure. During the time of participating in the study, the use of the normal blood pressure medication will be replaced with the medication assigned during the study. The medications will be inserted into identical capsules by the study pharmacy so that neither participants nor the investigators will know which medication is being used.
Study staff will monitor blood pressure during the study under the supervision of a board-certified cardiologist, and any necessary adjustments to the medication will be indicated by the physician. Participants will also be provided with a blood pressure monitor to use at home during the study and asked to check blood pressure each day and report any abnormal values to study staff. This monitor also automatically records each blood pressure reading. Please bring this monitor to each assessment visit so that study staff can download the stored blood pressure readings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACE inhibitor + exercise | – | Behavioral: Exercise, Drug: ACE inhibitor + exerciseIn addition to exercise training, participants will receive an initial perindopril dose of 4 mg/day which will be titrated to 8 mg/day. |
| Thiazide diuretic + exercise | – | Behavioral: Exercise, Drug: Thiazide diuretic + exerciseIn addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day. |
| Angiotensin receptor blocker + exercise | – | Behavioral: Exercise, Drug: Angiotensin receptor blocker + exerciseIn addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Aging adults with hypertension and physical limitation within Alachua County
Key inclusion criteria (6 listed)
- Age 65 years and older
- Hypertension - untreated (Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg) or treated
- Physical limitations evidenced by either:
- Score ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.2 m/sec during 400 m usual-paced test
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
Key exclusion criteria (20 listed)
- Failure to provide informed consent
- Inability to complete 400 m walk within 15 minutes without sitting or interpersonal assistance, as an indicator of disablement and likely inability to fully engage in the exercise intervention
- Primary indication for ACE inhibitor use, i.e. Congestive Heart Failure, CAD, diabetes
- Known hypersensitivity to ACE inhibitors
- Resistant hypertension, defined as BP > 140/90, despite the use of three or more anti-hypertensive drugs
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 |
|---|---|---|
| ExerciseAll participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week. | Behavioural | ACE inhibitor + exercise, Angiotensin receptor blocker + exercise, Thiazide diuretic + exercise |
| ACE inhibitor + exerciseAlso: PerindoprilIn addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day. | Drug | ACE inhibitor + exercise |
| Thiazide diuretic + exerciseAlso: HydrochlorothiazideIn addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day. | Drug | Thiazide diuretic + exercise |
| Angiotensin receptor blocker + exerciseAlso: LosartanIn addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day. | Drug | Angiotensin receptor blocker + exercise |
Primary outcome
Change in Walking Speed
Time frame: Baseline, 6 months
Investigators will assess walking speed by asking the participants to walk at their usual pace over a 4 m course. Participants will be instructed to stand with both feet touching the starting line and to start walking after a specific verbal command.
3 secondary outcomes
Change in body composition
Time frame: Baseline, 6 months
Changes in circulating indices of cardiovascular risk
Time frame: Baseline, 6 months
Change in Exercise Capacity
Time frame: Baseline, 6 months
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 5 Jul 2017.
- University of Florida Institute on AgingLink provided by the sponsor.
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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.
Thomas Buford, Ph.D. principal investigator
University of Florida Department of Aging and Geriatric Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Aging, run by University of Florida 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 6 inclusion and 20 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 5 Jul 2017. 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 Walking Speed (time frame: Baseline, 6 months). 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 5 Jul 2017.