Trial Outcomes & Findings for The Effects of Swimming on Elderly Women With Stage-2 Hypertension (NCT NCT03546270)
NCT ID: NCT03546270
Last Updated: 2020-11-18
Results Overview
via Pulse Wave Velocity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
20-weeks
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Swimming
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
48
|
|
Overall Study
COMPLETED
|
52
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Swimming on Elderly Women With Stage-2 Hypertension
Baseline characteristics by cohort
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 4 • n=5 Participants
|
73 years
STANDARD_DEVIATION 4 • n=7 Participants
|
74 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Pressure wave reflection
|
31 percent
STANDARD_DEVIATION 3 • n=5 Participants
|
30 percent
STANDARD_DEVIATION 2 • n=7 Participants
|
31 percent
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Systolic Blood Pressure
|
146 mmHg
STANDARD_DEVIATION 1.7 • n=5 Participants
|
144 mmHg
STANDARD_DEVIATION 1 • n=7 Participants
|
145 mmHg
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Diastolic Blood Pressure
|
88 mmHg
STANDARD_DEVIATION 1.7 • n=5 Participants
|
91 mmHg
STANDARD_DEVIATION 1 • n=7 Participants
|
90 mmHg
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Arterial stiffness
|
9.0 m/s
STANDARD_DEVIATION 0.2 • n=5 Participants
|
9.4 m/s
STANDARD_DEVIATION 0.2 • n=7 Participants
|
9.2 m/s
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Muscular strength
|
24 kg
STANDARD_DEVIATION 1 • n=5 Participants
|
25 kg
STANDARD_DEVIATION 1 • n=7 Participants
|
25 kg
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Cardiorespiratory endurance
|
22 mL/kg/min
STANDARD_DEVIATION 2 • n=5 Participants
|
24 mL/kg/min
STANDARD_DEVIATION 3 • n=7 Participants
|
23 mL/kg/min
STANDARD_DEVIATION 3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 20-weeksvia Pulse Wave Velocity
Outcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Arterial Stiffness
|
7.8 m/s
Standard Deviation 0.3
|
10.0 m/s
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 20-weekssystolic blood pressure
Outcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Systolic Blood Pressure
|
135 millimeters of mercury (mmHg)
Standard Deviation 1
|
145 millimeters of mercury (mmHg)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 20-weeksvia Augmentation Index
Outcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Pressure Wave Reflection
|
25 % of wave reflection
Standard Deviation 2
|
31 % of wave reflection
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 20-weeksvia Hand Grip Dynamometer
Outcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Muscular Strength
|
27 kilograms (kg)
Standard Deviation 1
|
24 kilograms (kg)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 20-weeksvia Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test
Outcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
|
26 mL/kg/min
Standard Deviation 3
|
23 mL/kg/min
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 20 weeksOutcome measures
| Measure |
Swimming
n=52 Participants
Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at \~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate
Swimming: This group completed 20-weeks of swimming
|
Control
n=48 Participants
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|---|---|---|
|
Diastolic Blood Pressure
|
79 millimeters of mercury (mmHg)
Standard Deviation 1
|
91 millimeters of mercury (mmHg)
Standard Deviation 1
|
Adverse Events
Swimming
Serious events: 0 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
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Song-Young Park
The University of Nebraska at Omaha
Phone: 402-554-3374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place