- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01874132
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
March 24, 2017 updated by: Nelson Joaquim Fortuna de Sousa, University of Trás-os-Montes and Alto Douro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Maia, Portugal, 4470-384
- Maia City Council facilities
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 79 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Older adults living independently;
- medical approval.
Exclusion Criteria:
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic exercise training
Dose response
|
Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
Other Names:
|
Experimental: Aerobic and resistance exercise training
Dose response
|
Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
Other Names:
|
No Intervention: Control
Non-exercising control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk of Falls
Time Frame: One year
|
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).
|
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: One year
|
Measured by the Satisfaction With Life Scale.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nelson Sousa, PhD, Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto Douro
- Study Director: José Oliveira, PhD, Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of Porto
- Study Chair: Romeu Mendes, MD, University of Trás-os-Montes and Alto Douro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Sousa 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.
- Sousa 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.
- Sousa 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.
- Sousa 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.
- Sousa 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.
- Sousa 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
June 6, 2013
First Submitted That Met QC Criteria
June 6, 2013
First Posted (Estimate)
June 10, 2013
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Body Weight
- Musculoskeletal Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Bone Diseases
- Muscular Atrophy
- Atrophy
- Bone Diseases, Metabolic
- Hypertension
- Overweight
- Sarcopenia
- Osteoporosis
- Metabolic Diseases
- Lipid Metabolism Disorders
Other Study ID Numbers
- CVD-2009-EX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lipid Metabolism Disorders
-
University of Texas Southwestern Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingLipid Metabolism DisorderUnited States
-
Université de SherbrookeHospices Civils de LyonCompleted
-
Merck Sharp & Dohme LLCCompletedLipid Metabolism Disorder
-
Organon and CoCompleted
-
Luye Pharma Group Ltd.CompletedLipid Metabolism DisorderUnited States
-
Hasselt UniversityRecruitingExercise | Sedentary Behavior | Lipid Metabolism DisorderBelgium
-
Johns Hopkins UniversityVAP Diagnostics LabActive, not recruiting
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
NewAmsterdam PharmaUniversity of PennsylvaniaRecruiting
-
Shandong Provincial HospitalRecruitingMetabolism and Nutrition Disorder | Rhythm Nodal | Metabolism Disorder, LipidChina
Clinical Trials on Exercise training
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Hacettepe UniversityCompleted