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

Primary Purpose

Hypertension With Complications and Secondary Hypertension, Overweight and Obesity, Lipid Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Trás-os-Montes and Alto Douro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension With Complications and Secondary Hypertension focused on measuring Exercise, Blood pressure, Lipids, Body composition, Fitness, Bone density, Quality of life

Eligibility Criteria

65 Years - 79 Years (Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Maia City Council facilities

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Aerobic exercise training

Aerobic and resistance exercise training

Control

Arm Description

Dose response

Dose response

Non-exercising control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 6, 2013
Last Updated
March 24, 2017
Sponsor
University of Trás-os-Montes and Alto Douro
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1. Study Identification

Unique Protocol Identification Number
NCT01874132
Brief Title
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
Official Title
A Randomised Longitudinal Study of Exercise Prescription for Older Adults: Mode and Intensity to Induce the Highest Cardiovascular Health-related Benefits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trás-os-Montes and Alto Douro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise training
Arm Type
Experimental
Arm Description
Dose response
Arm Title
Aerobic and resistance exercise training
Arm Type
Experimental
Arm Description
Dose response
Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-exercising control group
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Aerobic training, resistance training, Combined training, multicomponent training
Intervention Description
Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
Primary Outcome Measure Information:
Title
Cardiovascular Disease Risk Factors
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Risk of Falls
Description
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).
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
Measured by the Satisfaction With Life Scale.
Time Frame
One year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Sousa, PhD
Organizational Affiliation
Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto Douro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Oliveira, PhD
Organizational Affiliation
Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of Porto
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Romeu Mendes, MD
Organizational Affiliation
University of Trás-os-Montes and Alto Douro
Official's Role
Study Chair
Facility Information:
Facility Name
Maia City Council facilities
City
Maia
ZIP/Postal Code
4470-384
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
24628645
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. No abstract available.
Results Reference
background
PubMed Identifier
23441809
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):928-35. doi: 10.1111/ggi.12033. Epub 2013 Feb 26.
Results Reference
result
PubMed Identifier
23628502
Citation
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.
Results Reference
result
PubMed Identifier
23937497
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. No abstract available.
Results Reference
result
PubMed Identifier
24779956
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 Apr 30.
Results Reference
result
PubMed Identifier
25009971
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.
Results Reference
result
PubMed Identifier
27353246
Citation
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.
Results Reference
result

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

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