Trial record 2 of 9 for:    Dose-Response Study of Exercise in Older Adults

Study of the Long-term Effects of Exercise on Heath Indicators in Older People

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nelson Joaquim Fortuna de Sousa, University of Trás-os-Montes and Alto Douro
ClinicalTrials.gov Identifier:
NCT01874132
First received: June 6, 2013
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hypertension With Complications and Secondary Hypertension
Overweight and Obesity
Lipid Metabolism Disorders
Sarcopenia
Osteoporosis
Personal Satisfaction
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits

Resource links provided by NLM:


Further study details as provided by University of Trás-os-Montes and Alto Douro:

Primary Outcome Measures:
  • Cardiovascular disease risk factors [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    Bioelectrical impedance analysis to measure body fat percentage (%), fat-free mass (k) and dry lean mass (Kg).

    Electronic sphygmomanometer to measure systolic blood pressure (mmHg) and diastolic blood pressure (mmHg).

    Peripheral blood samples to collect serum lipid triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL) and high-density lipoprotein cholesterol (mg/dL), and analyzed by enzymatic techniques.



Secondary Outcome Measures:
  • Physical fitness [ Time Frame: One year ] [ Designated as safety issue: No ]

    Functional fitness was assessed according to the Fullerton Functional Fitness Test, and included 6 independent tests: 30-s chair stand (repetitions), arm curl (repetitions), chair sit-and-reach (cm), back scratch (cm), 8-foot up-and-go (s) and 6-min walk (m).

    Falls risk was measured by the timed up-and-go test (seconds) and the functional reach test (cm).



Other Outcome Measures:
  • Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measured by the Satisfaction With Life Scale.


Enrollment: 90
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise training
Dose response
Behavioral: Exercise training
Other Names:
  • Aerobic training
  • resistance training
  • Combined training
  • multicomponent training
Experimental: Aerobic and resistance exercise training
Dose response
Behavioral: Exercise training
Other Names:
  • Aerobic training
  • resistance training
  • Combined training
  • multicomponent training
No Intervention: Control
Non-exercising control group

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874132

Locations
Portugal
Maia City Council facilities
Maia, Portugal, 4470-384
Sponsors and Collaborators
University of Trás-os-Montes and Alto Douro
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
  More Information

Publications:
Responsible Party: Nelson Joaquim Fortuna de Sousa, Professor, University of Trás-os-Montes and Alto Douro
ClinicalTrials.gov Identifier: NCT01874132     History of Changes
Other Study ID Numbers: CVD-2009-EX
Study First Received: June 6, 2013
Last Updated: August 7, 2013
Health Authority: Portugal: Health Ethic Committee

Keywords provided by University of Trás-os-Montes and Alto Douro:
Exercise
Blood pressure
Lipids
Body composition
Fitness
Bone density
Quality of life

Additional relevant MeSH terms:
Hypertension
Metabolic Diseases
Obesity
Osteoporosis
Lipid Metabolism Disorders
Sphingolipidoses
Overweight
Sarcopenia
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Muscular Atrophy
Neuromuscular Manifestations

ClinicalTrials.gov processed this record on April 20, 2014