Trial Outcomes & Findings for Study of the Long-term Effects of Exercise on Heath Indicators in Older People (NCT NCT01874132)
NCT ID: NCT01874132
Last Updated: 2017-05-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
one year
Results posted on
2017-05-08
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise Training
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
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.
|
Control
Non-exercising control group
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
Baseline characteristics by cohort
| Measure |
Aerobic Exercise Training
n=22 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Aerobic and Resistance Exercise Training
n=22 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Control
n=22 Participants
Non-exercising control group
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
66 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.
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.
Outcome measures
| Measure |
Aerobic Exercise Training
n=15 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Aerobic and Resistance Exercise Training
n=16 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Control
n=17 Participants
Non-exercising control group
|
|---|---|---|---|
|
Cardiovascular Disease Risk Factors
1 risk-factor
|
7 participants
|
5 participants
|
8 participants
|
|
Cardiovascular Disease Risk Factors
2 risk-factors
|
5 participants
|
7 participants
|
4 participants
|
|
Cardiovascular Disease Risk Factors
0 risk-factors
|
3 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: One 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).
Outcome measures
| Measure |
Aerobic Exercise Training
n=22 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Aerobic and Resistance Exercise Training
n=22 Participants
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Control
n=22 Participants
Non-exercising control group
|
|---|---|---|---|
|
Risk of Falls
High risk of fall (TUG≥12 seconds)
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Risk of Falls
Low risk of fall
|
15 Participants
|
16 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearMeasured by the Satisfaction With Life Scale.
Outcome measures
Outcome data not reported
Adverse Events
Aerobic Exercise Training
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Aerobic and Resistance Exercise Training
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aerobic Exercise Training
n=22 participants at risk
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Aerobic and Resistance Exercise Training
n=22 participants at risk
Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
|
Control
n=22 participants at risk
Non-exercising control group
|
|---|---|---|---|
|
Vascular disorders
Postural orthostatic hypotension during the study
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Fall during the study
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
Other adverse events
Adverse event data not reported
Additional Information
Professor Nelson Sousa
University of Trás-os-Montes e Alto Douro
Phone: 259350756
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place