Hypertension With Complications and Secondary HypertensionNCT01874132
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
A study testing Exercise training in people with Hypertension With Complications and Secondary Hypertension and Overweight and Obesity, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial summary
Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. Read more about this study
- Who is it for?
- Ages 65 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension With Complications and Secondary Hypertension, Overweight and Obesity, Lipid Metabolism Disorders
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- May 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older adults living independently;
- medical approval.
Who cannot join
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits
Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American College of Sports Medicine, and the American Heart Association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.The same organizations also suggest the inclusion of resistance training in order to improve functional fitness. Therefore, the purpose of this study was to compare different exercise modalities in long-term changes of CVD risk factors and physical fitness among older adults.
- Conditions
- Hypertension With Complications and Secondary Hypertension, Overweight and Obesity, Lipid Metabolism Disorders, Sarcopenia, Osteoporosis, Personal Satisfaction
- Being tested
- Exercise training
- Keywords
- Exercise, Blood pressure, Lipids, Body composition, Fitness, Bone density, Quality of life
- Medical subject headings
- Overweight, Obesity, Lipid Metabolism Disorders, Sarcopenia, Osteoporosis, Personal Satisfaction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Also called Aerobic training, resistance training, Combined training, multicomponent training
Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training | Experimental | Dose response Receives: Behavioral: Exercise training |
| Aerobic and resistance exercise training | Experimental | Dose response Receives: Behavioral: Exercise training |
| Control | No intervention | Non-exercising control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Disease Risk Factors
Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.
Measured: one year
Secondary outcomes (1)
Risk of Falls
Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypertension With Complications and Secondary HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Joaquim Fortuna de Sousa, University of Trás-os-Montes and Alto Douro
- Investigators
- Nelson Sousa, PhD, Principal investigator, Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto DouroJosé Oliveira, PhD, Study director, Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of PortoRomeu Mendes, MD, Study chair, University of Trás-os-Montes and Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874132
- Sponsor's protocol ID
- CVD-2009-EX
- Status last verified
- Mar 2017
- First submitted
- 6 Jun 2013
- Last updated
- 8 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sousa N, Mendes R, Oliveira J. Response to Drs. Safer and Safer. J Am Geriatr Soc. 2014 Mar;62(3):590-1. doi: 10.1111/jgs.12712. No abstract available.
PubMed 24628645Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Long-term effects of aerobic training versus combined aerobic and resistance training in modifying cardiovascular disease risk factors in healthy elderly men. Geriatr Gerontol Int. 2013 Oct;13(4):928-35. doi: 10.1111/ggi.12033. Epub 2013 Feb 26.
PubMed 23441809Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized 9-month study of blood pressure and body fat responses to aerobic training versus combined aerobic and resistance training in older men. Exp Gerontol. 2013 Aug;48(8):727-33. doi: 10.1016/j.exger.2013.04.008. Epub 2013 Apr 26.
PubMed 23628502Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Is once-weekly resistance training enough to prevent sarcopenia? J Am Geriatr Soc. 2013 Aug;61(8):1423-4. doi: 10.1111/jgs.12387. No abstract available.
PubMed 23937497Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial. Geriatr Gerontol Int. 2014 Oct;14(4):892-8. doi: 10.1111/ggi.12188. Epub 2014 Apr 30.
PubMed 24779956Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized study on lipids response to different exercise programs in overweight older men. Int J Sports Med. 2014 Dec;35(13):1106-11. doi: 10.1055/s-0034-1374639. Epub 2014 Jul 10.
PubMed 25009971Sousa N, Mendes R, Silva A, Oliveira J. Combined exercise is more effective than aerobic exercise in the improvement of fall risk factors: a randomized controlled trial in community-dwelling older men. Clin Rehabil. 2017 Apr;31(4):478-486. doi: 10.1177/0269215516655857. Epub 2016 Jul 10.
PubMed 27353246
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits
- ClinicalTrials.gov ID
- NCT01874132
- Acronym / sponsor ID
- CVD-2009-EX
- Conditions
- Hypertension With Complications and Secondary Hypertension, Overweight and Obesity, Lipid Metabolism Disorders, Sarcopenia, Osteoporosis, Personal Satisfaction
- Keywords
- Exercise, Blood pressure, Lipids, Body composition, Fitness, Bone density, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American College of Sports Medicine, and the American Heart Association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.The same organizations also suggest the inclusion of resistance training in order to improve functional fitness. Therefore, the purpose of this study was to compare different exercise modalities in long-term changes of CVD risk factors and physical fitness among older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Behavioral: Exercise trainingDose response |
| Aerobic and resistance exercise training | Experimental | Behavioral: Exercise trainingDose response |
| Control | No intervention | –Non-exercising control group |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Older adults living independently;
- medical approval.
Key exclusion criteria (5 listed)
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
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 |
|---|---|---|
| Exercise trainingAlso: Aerobic training, resistance training, Combined training, multicomponent trainingBoth training programs were of moderate-to-vigorous intensity, three days per week for nine months. | Behavioural | Aerobic and resistance exercise training, Aerobic exercise training |
Primary outcome
Cardiovascular Disease Risk Factors
Time frame: one year
Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.
1 secondary outcome
Risk of Falls
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24628645Sousa N, Mendes R, Oliveira J. Response to Drs. Safer and Safer. J Am Geriatr Soc. 2014 Mar;62(3):590-1. doi: 10.1111/jgs.12712. No abstract available.
- Results publication: PubMed 23441809Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Long-term effects of aerobic training versus combined aerobic and resistance training in modifying cardiovascular disease risk factors in healthy elderly men. Geriatr Gerontol Int. 2013 Oct;13(4):928-35. doi: 10.1111/ggi.12033. Epub 2013 Feb 26.
- Results publication: PubMed 23628502Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized 9-month study of blood pressure and body fat responses to aerobic training versus combined aerobic and resistance training in older men. Exp Gerontol. 2013 Aug;48(8):727-33. doi: 10.1016/j.exger.2013.04.008. Epub 2013 Apr 26.
- Results publication: PubMed 23937497Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Is once-weekly resistance training enough to prevent sarcopenia? J Am Geriatr Soc. 2013 Aug;61(8):1423-4. doi: 10.1111/jgs.12387. No abstract available.
- Results publication: PubMed 24779956Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial. Geriatr Gerontol Int. 2014 Oct;14(4):892-8. doi: 10.1111/ggi.12188. Epub 2014 Apr 30.
- Results publication: PubMed 25009971Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized study on lipids response to different exercise programs in overweight older men. Int J Sports Med. 2014 Dec;35(13):1106-11. doi: 10.1055/s-0034-1374639. Epub 2014 Jul 10.
- Results publication: PubMed 27353246Sousa N, Mendes R, Silva A, Oliveira J. Combined exercise is more effective than aerobic exercise in the improvement of fall risk factors: a randomized controlled trial in community-dwelling older men. Clin Rehabil. 2017 Apr;31(4):478-486. doi: 10.1177/0269215516655857. Epub 2016 Jul 10.
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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.
Nelson Sousa, PhD principal investigator
Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto Douro
José Oliveira, PhD study director
Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of Porto
Romeu Mendes, MD study chair
University of Trás-os-Montes and Alto Douro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Hypertension With Complications and Secondary Hypertension and Overweight and Obesity, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
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 2 inclusion and 5 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 8 May 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 Portugal. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiovascular Disease Risk Factors (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874132, which also lists 7 linked publications.
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 8 May 2017.