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

Osteoporosis Clinical Trial

Official title:

A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874132
• Other study ID #: CVD-2009-EX
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: May 13, 2015
• Start date: May 2011
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: University of Trás-os-Montes and Alto Douro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2014
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension With Complications and Secondary Hypertension
• Lipid Metabolism Disorders
• Metabolic Diseases
• Osteoporosis
• Overweight and Obesity
• Personal Satisfaction
• Sarcopenia

Intervention

Behavioral:
• Exercise training
Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.

Locations

Country	Name	City	State
Portugal	Maia City Council facilities	Maia

Sponsors (1)

Lead Sponsor	Collaborator
University of Trás-os-Montes and Alto Douro

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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 — View Citation

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. — View Citation

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 A — View Citation

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. — View Citation

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):928-3 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Measured by the Satisfaction With Life Scale.	One year	No
Primary	Cardiovascular disease risk factors	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.	one year	Yes
Secondary	Physical fitness	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).	One year	No