Trial Outcomes & Findings for The Effect of Different Volumes of Physical Exercise on the Immune System (NCT NCT02331446)
NCT ID: NCT02331446
Last Updated: 2016-09-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Weeks 0, 6 and 12
Results posted on
2016-09-29
Participant Flow
Participant milestones
| Measure |
Control
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
5
|
6
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
3
|
3
|
Reasons for withdrawal
| Measure |
Control
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
1
|
|
Overall Study
Personal Problem
|
2
|
0
|
0
|
0
|
|
Overall Study
Disease
|
0
|
2
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost before baseline analysis
|
0
|
1
|
1
|
0
|
Baseline Characteristics
The Effect of Different Volumes of Physical Exercise on the Immune System
Baseline characteristics by cohort
| Measure |
Control
n=9 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=10 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=10 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=11 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
62 years
n=107 Participants
|
61.5 years
n=206 Participants
|
63 years
n=7 Participants
|
63 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
11 participants
n=7 Participants
|
40 participants
n=31 Participants
|
|
Household Income
|
846 US$
n=99 Participants
|
538 US$
n=107 Participants
|
867 US$
n=206 Participants
|
423 US$
n=7 Participants
|
612 US$
n=31 Participants
|
|
Resting heart rate
|
65.8 bpm
STANDARD_DEVIATION 7.9 • n=99 Participants
|
64.7 bpm
STANDARD_DEVIATION 13.1 • n=107 Participants
|
64.5 bpm
STANDARD_DEVIATION 9.2 • n=206 Participants
|
68.1 bpm
STANDARD_DEVIATION 12.1 • n=7 Participants
|
65.5 bpm
STANDARD_DEVIATION 10.6 • n=31 Participants
|
|
Systolic blood pressure
|
119.8 mmHg
STANDARD_DEVIATION 6.7 • n=99 Participants
|
118.2 mmHg
STANDARD_DEVIATION 20.4 • n=107 Participants
|
121.2 mmHg
STANDARD_DEVIATION 12.4 • n=206 Participants
|
121.0 mmHg
STANDARD_DEVIATION 14.2 • n=7 Participants
|
120.8 mmHg
STANDARD_DEVIATION 14.3 • n=31 Participants
|
|
Diastolic blood pressure
|
74.4 mmHg
STANDARD_DEVIATION 8.8 • n=99 Participants
|
75.2 mmHg
STANDARD_DEVIATION 17.2 • n=107 Participants
|
76.0 mmHg
STANDARD_DEVIATION 7.0 • n=206 Participants
|
78.7 mmHg
STANDARD_DEVIATION 7.1 • n=7 Participants
|
76.4 mmHg
STANDARD_DEVIATION 10.6 • n=31 Participants
|
|
Marital status
Married
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
1 participants
n=7 Participants
|
16 participants
n=31 Participants
|
|
Marital status
Others
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
3 participants
n=206 Participants
|
10 participants
n=7 Participants
|
24 participants
n=31 Participants
|
|
Educational level
Incomplete primary school
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
4 participants
n=7 Participants
|
12 participants
n=31 Participants
|
|
Educational level
Primary school
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
9 participants
n=31 Participants
|
|
Educational level
Incomplete high school
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
4 participants
n=31 Participants
|
|
Educational level
High school
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
2 participants
n=7 Participants
|
10 participants
n=31 Participants
|
|
Educational level
Incomplete higher education
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
2 participants
n=31 Participants
|
|
Educational level
Higher education
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Chronic Use of Medication
No
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Chronic Use of Medication
Yes
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
10 participants
n=7 Participants
|
37 participants
n=31 Participants
|
|
Smoking
No
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
9 participants
n=206 Participants
|
10 participants
n=7 Participants
|
35 participants
n=31 Participants
|
|
Smoking
Yes
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Alcohol intake
Daily (one dose)
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Alcohol intake
Sporadically
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
5 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Alcohol intake
No
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
18 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Interleukin-6
Baseline
|
4.60 pg/mL
Interval 3.96 to 5.77
|
4.58 pg/mL
Interval 3.62 to 4.88
|
4.50 pg/mL
Interval 3.84 to 6.35
|
5.27 pg/mL
Interval 4.05 to 13.01
|
|
Change in Interleukin-6
Week 6
|
3.62 pg/mL
Interval 3.42 to 4.41
|
4.14 pg/mL
Interval 3.54 to 4.29
|
4.39 pg/mL
Interval 4.06 to 4.87
|
4.67 pg/mL
Interval 3.67 to 6.69
|
|
Change in Interleukin-6
Week 12
|
4.47 pg/mL
Interval 4.26 to 4.54
|
3.82 pg/mL
Interval 3.57 to 8.92
|
4.71 pg/mL
Interval 3.46 to 5.39
|
5.55 pg/mL
Interval 3.97 to 7.01
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Adenosine Deaminase Activity
Baseline
|
31.12 U/L
Standard Deviation 5.96
|
29.94 U/L
Standard Deviation 11.72
|
31.83 U/L
Standard Deviation 5.84
|
25.91 U/L
Standard Deviation 8.45
|
|
Change in Adenosine Deaminase Activity
Week 6
|
42.11 U/L
Standard Deviation 10.74
|
42.54 U/L
Standard Deviation 10.07
|
42.34 U/L
Standard Deviation 11.53
|
45.03 U/L
Standard Deviation 9.05
|
|
Change in Adenosine Deaminase Activity
Week 12
|
43.11 U/L
Standard Deviation 20.21
|
45.89 U/L
Standard Deviation 9.75
|
37.83 U/L
Standard Deviation 10.51
|
47.70 U/L
Standard Deviation 17.90
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Butyrylcholinesterase Activity
Baseline
|
9.35 µmol BuSCh/h/mg of protein
Standard Deviation 2.79
|
10.83 µmol BuSCh/h/mg of protein
Standard Deviation 2.00
|
7.44 µmol BuSCh/h/mg of protein
Standard Deviation 4.31
|
7.31 µmol BuSCh/h/mg of protein
Standard Deviation 4.23
|
|
Change in Butyrylcholinesterase Activity
Week 6
|
10.07 µmol BuSCh/h/mg of protein
Standard Deviation 0.83
|
11.46 µmol BuSCh/h/mg of protein
Standard Deviation 2.83
|
9.40 µmol BuSCh/h/mg of protein
Standard Deviation 2.85
|
11.02 µmol BuSCh/h/mg of protein
Standard Deviation 2.83
|
|
Change in Butyrylcholinesterase Activity
Week 12
|
11.16 µmol BuSCh/h/mg of protein
Standard Deviation 1.65
|
9.49 µmol BuSCh/h/mg of protein
Standard Deviation 1.28
|
8.71 µmol BuSCh/h/mg of protein
Standard Deviation 1.78
|
10.34 µmol BuSCh/h/mg of protein
Standard Deviation 2.77
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Thiobarbituric Acid Reactive Substances
Baseline
|
0.100 nmol TBARS/mg protein
Standard Deviation 0.022
|
0.144 nmol TBARS/mg protein
Standard Deviation 0.039
|
0.131 nmol TBARS/mg protein
Standard Deviation 0.028
|
0.137 nmol TBARS/mg protein
Standard Deviation 0.017
|
|
Change in Thiobarbituric Acid Reactive Substances
Week 6
|
0.119 nmol TBARS/mg protein
Standard Deviation 0.020
|
0.159 nmol TBARS/mg protein
Standard Deviation 0.053
|
0.162 nmol TBARS/mg protein
Standard Deviation 0.049
|
0.149 nmol TBARS/mg protein
Standard Deviation 0.018
|
|
Change in Thiobarbituric Acid Reactive Substances
Week 12
|
0.073 nmol TBARS/mg protein
Standard Deviation 0.040
|
0.095 nmol TBARS/mg protein
Standard Deviation 0.020
|
0.062 nmol TBARS/mg protein
Standard Deviation 0.024
|
0.070 nmol TBARS/mg protein
Standard Deviation 0.019
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Total Thiol Content
Baseline
|
9.00 nmol TNB/mg protein
Standard Deviation 1.45
|
7.74 nmol TNB/mg protein
Standard Deviation 0.94
|
7.73 nmol TNB/mg protein
Standard Deviation 1.85
|
7.07 nmol TNB/mg protein
Standard Deviation 1.63
|
|
Change in Total Thiol Content
Week 6
|
12.26 nmol TNB/mg protein
Standard Deviation 2.50
|
12.10 nmol TNB/mg protein
Standard Deviation 3.69
|
12.42 nmol TNB/mg protein
Standard Deviation 4.31
|
12.13 nmol TNB/mg protein
Standard Deviation 3.65
|
|
Change in Total Thiol Content
Week 12
|
9.24 nmol TNB/mg protein
Standard Deviation 1.44
|
8.55 nmol TNB/mg protein
Standard Deviation 2.53
|
7.80 nmol TNB/mg protein
Standard Deviation 1.51
|
8.32 nmol TNB/mg protein
Standard Deviation 1.52
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Glutathione Peroxidase Activity
Baseline
|
87.32 U/mg protein
Standard Deviation 15.68
|
63.69 U/mg protein
Standard Deviation 41.12
|
73.53 U/mg protein
Standard Deviation 40.56
|
65.31 U/mg protein
Standard Deviation 29.52
|
|
Change in Glutathione Peroxidase Activity
Week 6
|
90.24 U/mg protein
Standard Deviation 11.99
|
91.26 U/mg protein
Standard Deviation 44.79
|
80.57 U/mg protein
Standard Deviation 43.76
|
98.87 U/mg protein
Standard Deviation 33.17
|
|
Change in Glutathione Peroxidase Activity
Week 12
|
93.08 U/mg protein
Standard Deviation 13.84
|
81.72 U/mg protein
Standard Deviation 12.52
|
80.04 U/mg protein
Standard Deviation 18.26
|
77.32 U/mg protein
Standard Deviation 13.01
|
PRIMARY outcome
Timeframe: Weeks 0, 6 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Superoxide Dismutase Activity
Baseline
|
6.10 U/mg protein
Standard Deviation 1.33
|
5.31 U/mg protein
Standard Deviation 0.79
|
5.72 U/mg protein
Standard Deviation 1.44
|
4.67 U/mg protein
Standard Deviation 1.11
|
|
Change in Superoxide Dismutase Activity
Week 6
|
6.04 U/mg protein
Standard Deviation 0.62
|
5.04 U/mg protein
Standard Deviation 1.67
|
4.20 U/mg protein
Standard Deviation 0.79
|
5.02 U/mg protein
Standard Deviation 1.15
|
|
Change in Superoxide Dismutase Activity
Week 12
|
6.36 U/mg protein
Standard Deviation 0.31
|
4.79 U/mg protein
Standard Deviation 1.29
|
4.86 U/mg protein
Standard Deviation 1.06
|
4.78 U/mg protein
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Weeks 0 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Performance in the Six-minute Walk Test
Baseline
|
466.49 Meters
Standard Deviation 97.89
|
515.78 Meters
Standard Deviation 69.08
|
552.62 Meters
Standard Deviation 62.29
|
539.77 Meters
Standard Deviation 46.17
|
|
Change in Performance in the Six-minute Walk Test
Week 12
|
514.5 Meters
Standard Deviation 124.24
|
581.02 Meters
Standard Deviation 76.02
|
559.57 Meters
Standard Deviation 53.03
|
586.69 Meters
Standard Deviation 66.53
|
SECONDARY outcome
Timeframe: Weeks 0 and 12Measured using a handgrip dynamometer and quantified in kilogram-force
Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Handgrip Strength
Baseline
|
23.61 kgf
Standard Deviation 3.91
|
23.80 kgf
Standard Deviation 5.46
|
25.03 kgf
Standard Deviation 5.70
|
24.81 kgf
Standard Deviation 4.23
|
|
Change in Handgrip Strength
Week 12
|
22.98 kgf
Standard Deviation 4.92
|
26.56 kgf
Standard Deviation 5.76
|
26.67 kgf
Standard Deviation 6.64
|
30.39 kgf
Standard Deviation 4.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 0 and 12Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Body Mass Index
Baseline
|
29.69 kg/m²
Interval 28.14 to 34.98
|
28.25 kg/m²
Interval 23.84 to 31.96
|
28.62 kg/m²
Interval 23.61 to 30.44
|
29.56 kg/m²
Interval 24.49 to 30.68
|
|
Change in Body Mass Index
Week 12
|
28.09 kg/m²
Interval 27.35 to 31.12
|
28.03 kg/m²
Interval 23.71 to 29.61
|
28.97 kg/m²
Interval 24.54 to 30.15
|
28.20 kg/m²
Interval 24.74 to 32.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 and 12Measured by the commuting and leisure sections of the International Physical Activity Questionnaire
Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Minutes Per Week of Physical Activity Out of Intervention
Baseline
|
30 minutes per week
Interval 0.0 to 120.0
|
35 minutes per week
Interval 0.0 to 200.0
|
60 minutes per week
Interval 0.0 to 120.0
|
150 minutes per week
Interval 80.0 to 300.0
|
|
Change in Minutes Per Week of Physical Activity Out of Intervention
Week 12
|
90 minutes per week
Interval 40.0 to 120.0
|
90 minutes per week
Interval 60.0 to 90.0
|
65 minutes per week
Interval 20.0 to 125.0
|
150 minutes per week
Interval 60.0 to 240.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 0 and 12Measured by a 24-hour food recall and quantified in calories
Outcome measures
| Measure |
Control
n=5 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=6 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=8 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=8 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Change in Calories Intake
Baseline
|
1700.45 cal
Standard Deviation 178.56
|
1390.64 cal
Standard Deviation 687.00
|
1461.53 cal
Standard Deviation 544.92
|
1485.54 cal
Standard Deviation 474.46
|
|
Change in Calories Intake
Week 12
|
1873.03 cal
Standard Deviation 531.22
|
1720.32 cal
Standard Deviation 534.82
|
1229.61 cal
Standard Deviation 550.19
|
1322.39 cal
Standard Deviation 317.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
Outcome measures
| Measure |
Control
n=9 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=10 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=10 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=11 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Educational Level
Incomplete primary school
|
1 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Educational Level
Primary school
|
3 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Educational Level
Incomplete high school
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Educational Level
High school
|
3 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Educational Level
Incomplete higher education
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Educational Level
Higher education
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
Outcome measures
| Measure |
Control
n=9 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=10 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=10 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=11 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Household Income
|
846 US$
Interval 612.0 to 1692.0
|
538 US$
Interval 338.0 to 846.0
|
867 US$
Interval 444.0 to 1269.0
|
423 US$
Interval 306.0 to 655.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
Outcome measures
| Measure |
Control
n=9 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=10 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=10 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=11 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Age
|
70 years
Interval 63.0 to 73.0
|
62 years
Interval 52.0 to 74.0
|
61.5 years
Interval 59.0 to 67.0
|
63 years
Interval 62.0 to 65.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
Outcome measures
| Measure |
Control
n=9 Participants
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
|
90 Minutes Per Week
n=10 Participants
The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention
|
150 Minutes Per Week
n=10 Participants
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
|
210 Minutes Per Week
n=11 Participants
The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention
|
|---|---|---|---|---|
|
Chronic Use of Medication
No
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Chronic Use of Medication
Yes
|
9 participants
|
9 participants
|
9 participants
|
10 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
90 Minutes Per Week
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150 Minutes Per Week
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
210 Minutes Per Week
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place