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CompletedNCT03546270Updated Nov 18, 2020Results posted

The Effects of Swimming on Elderly Women With Stage-2 Hypertension

An interventional study of Swimming in Menopause and Hypertension, sponsored by Pusan National University. Completed. Open to female participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Pusan National University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
Female
01

Study summary

Aging is associated with progressive decreases in arterial health and function as well as overall fitness. It is crucial to prevent or reduce the negative effects of aging on the vasculature and fitness components by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a swimming (SWM) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx), muscle strength and aerobic capacity in elderly women with stage 2 hypertension.

Read the detailed description

Using a parallel experimental design, participants were randomly assigned to either SWM (n=52) or non-exercising control group (n=48) for 20 weeks. Participant in the SWM group trained 3-4 days/week, progressing in duration from 25 to 45 min. Participants' carotid to radial PWV (crPWV), systolic and diastolic BP, AIx, strength and VO2max were measured at baseline and after 20 weeks of their assigned intervention.

02

Conditions studied

  • Menopause
  • Hypertension

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Keywords

  • Swimming
  • Arterial Stiffness
  • Blood Pressure
  • Muscular Strength
  • Cardiorespiratory Endurance
03

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • systolic/diastolic BP: 140-179 over 90-119 mm Hg
  • had experienced the absence of menstruation for at least 1 year
  • body mass index \<30 kg/m2
  • \<1 h of regular exercise per week in the previous year

Exclusion criteria

Exclusion Criteria:

  • Smoker
  • Taking any medications or hormone therapy in previous year
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: Swimming

  • No intervention
    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

Interventions

  • BehavioralSwimming

    This group completed 20-weeks of swimming

05

What researchers measure

Primary outcomes

  1. Arterial Stiffness

    via Pulse Wave Velocity

    Time frame: 20-weeks

Secondary outcomes

  1. Systolic Blood Pressure

    systolic blood pressure

    Time frame: 20-weeks

  2. Pressure Wave Reflection

    via Augmentation Index

    Time frame: 20-weeks

  3. Muscular Strength

    via Hand Grip Dynamometer

    Time frame: 20-weeks

  4. Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)

    via Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test

    Time frame: 20-weeks

  5. Diastolic Blood Pressure

    Time frame: 20 weeks

06

Results

Posted Aug 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneSwimmingControl
Started5248
Completed5248
Not completed00

Outcome measures

PrimaryArterial Stiffness

via Pulse Wave Velocity

Time frame:
20-weeks
Reported as:
Mean · m/s
Arterial Stiffness
m/sSwimmingControl
Arterial Stiffness7.8 ± 0.310.0 ± 0.2
SecondarySystolic Blood Pressure

systolic blood pressure

Time frame:
20-weeks
Reported as:
Mean · millimeters of mercury (mmHg)
Systolic Blood Pressure
millimeters of mercury (mmHg)SwimmingControl
Systolic Blood Pressure135 ± 1145 ± 1
SecondaryPressure Wave Reflection

via Augmentation Index

Time frame:
20-weeks
Reported as:
Mean · % of wave reflection
Pressure Wave Reflection
% of wave reflectionSwimmingControl
Pressure Wave Reflection25 ± 231 ± 2
SecondaryMuscular Strength

via Hand Grip Dynamometer

Time frame:
20-weeks
Reported as:
Mean · kilograms (kg)
Muscular Strength
kilograms (kg)SwimmingControl
Muscular Strength27 ± 124 ± 1
SecondaryCardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)

via Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test

Time frame:
20-weeks
Reported as:
Mean · mL/kg/min
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
mL/kg/minSwimmingControl
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)26 ± 323 ± 4
SecondaryDiastolic Blood Pressure
Time frame:
20 weeks
Reported as:
Mean · millimeters of mercury (mmHg)
Diastolic Blood Pressure
millimeters of mercury (mmHg)SwimmingControl
Diastolic Blood Pressure79 ± 191 ± 1

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Swimming0/52 (0%)0/52 (0%)0/52 (0%)
Control0/48 (0%)0/48 (0%)0/48 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)SwimmingControlTotal
Mean74 ± 473 ± 474 ± 4
Sex: Female, Male
Sex: Female, Male(Participants)SwimmingControlTotal
Female5248100
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SwimmingControlTotal
American Indian or Alaska Native000
Asian5248100
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Pressure wave reflection
Pressure wave reflection(percent)SwimmingControlTotal
Mean31 ± 330 ± 231 ± 3
Systolic Blood Pressure
Systolic Blood Pressure(mmHg)SwimmingControlTotal
Mean146 ± 1.7144 ± 1145 ± 1.4
Diastolic Blood Pressure
Diastolic Blood Pressure(mmHg)SwimmingControlTotal
Mean88 ± 1.791 ± 190 ± 1.4
Arterial stiffness
Arterial stiffness(m/s)SwimmingControlTotal
Mean9.0 ± 0.29.4 ± 0.29.2 ± 0.2
Muscular strength
Muscular strength(kg)SwimmingControlTotal
Mean24 ± 125 ± 125 ± 1

1 further baseline measures are reported on the registry.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Wong A, Kwak YS, Scott SD, Pekas EJ, Son WM, Kim JS, Park SY. The effects of swimming training on arterial function, muscular strength, and cardiorespiratory capacity in postmenopausal women with stage 2 hypertension. Menopause. 2018 Dec 17;26(6):653-658. doi: 10.1097/GME.0000000000001288. Erratum In: Menopause. 2020 May;27(5):610. doi: 10.1097/GME.0000000000001562. Menopause. 2021 Feb 1;28(2):230. doi: 10.1097/GME.0000000000001717. PubMed 30562322 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 25, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03546270
Lead sponsor
Pusan National University
Collaborators
Marymount University, Dong-Eui University, University of Nebraska
Responsible party
Won-mok son (Principal Investigator, Pusan National University) — Principal investigator
First posted
Jun 6, 2018
Start date
Jan 2017
Primary completion
Jan 2018
Completion
Apr 2018
Results posted
Aug 5, 2019
Last update
Nov 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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