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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01874132
Enrollment
66
Registered
2013-06-10
Start date
2011-05-31
Completion date
2014-09-30
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension With Complications and Secondary Hypertension, Lipid Metabolism Disorders, Osteoporosis, Overweight and Obesity, Personal Satisfaction, Sarcopenia

Keywords

Exercise, Blood pressure, Lipids, Body composition, Fitness, Bone density, Quality of life

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.

Interventions

BEHAVIORALExercise training

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

Sponsors

University of Trás-os-Montes and Alto Douro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
65 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular Disease Risk Factorsone yearDescriptive 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

MeasureTime frameDescription
Risk of FallsOne yearDescriptive 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).

Other

MeasureTime frameDescription
Quality of LifeOne yearMeasured by the Satisfaction With Life Scale.

Countries

Portugal

Participant flow

Participants by arm

ArmCount
Aerobic Exercise Training
Dose response Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
22
Aerobic and Resistance Exercise Training
Dose response Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
22
Control
Non-exercising control group
22
Total66

Baseline characteristics

CharacteristicAerobic and Resistance Exercise TrainingControlAerobic Exercise TrainingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
22 Participants22 Participants22 Participants66 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous71.3 years
STANDARD_DEVIATION 4.6
67.2 years
STANDARD_DEVIATION 5.5
69.0 years
STANDARD_DEVIATION 4.9
69.5 years
STANDARD_DEVIATION 4.5
Region of Enrollment
Portugal
22 participants22 participants22 participants66 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
22 Participants22 Participants22 Participants66 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 220 / 220 / 22
serious
Total, serious adverse events
1 / 222 / 220 / 22

Outcome results

Primary

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.

Time frame: one year

Population: Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.

ArmMeasureGroupValue (NUMBER)
Aerobic Exercise TrainingCardiovascular Disease Risk Factors1 risk-factor7 participants
Aerobic Exercise TrainingCardiovascular Disease Risk Factors0 risk-factors3 participants
Aerobic Exercise TrainingCardiovascular Disease Risk Factors2 risk-factors5 participants
Aerobic and Resistance Exercise TrainingCardiovascular Disease Risk Factors1 risk-factor5 participants
Aerobic and Resistance Exercise TrainingCardiovascular Disease Risk Factors0 risk-factors4 participants
Aerobic and Resistance Exercise TrainingCardiovascular Disease Risk Factors2 risk-factors7 participants
ControlCardiovascular Disease Risk Factors0 risk-factors5 participants
ControlCardiovascular Disease Risk Factors2 risk-factors4 participants
ControlCardiovascular Disease Risk Factors1 risk-factor8 participants
Secondary

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).

Time frame: One year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Aerobic Exercise TrainingRisk of FallsHigh risk of fall (TUG≥12 seconds)7 Participants
Aerobic Exercise TrainingRisk of FallsLow risk of fall15 Participants
Aerobic and Resistance Exercise TrainingRisk of FallsHigh risk of fall (TUG≥12 seconds)6 Participants
Aerobic and Resistance Exercise TrainingRisk of FallsLow risk of fall16 Participants
ControlRisk of FallsHigh risk of fall (TUG≥12 seconds)5 Participants
ControlRisk of FallsLow risk of fall17 Participants
Other Pre-specified

Quality of Life

Measured by the Satisfaction With Life Scale.

Time frame: One year

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026