- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546270
The Effects of Swimming on Elderly Women With Stage-2 Hypertension
October 30, 2020 updated by: Won-mok son, Pusan National University
The Effects of Swimming Training on Arterial Function, Strength and Cardiorespiratory Capacity in Elderly Women With Stage 2 Hypertension
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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:
- Smoker
- Taking any medications or hormone therapy in previous year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
This group completed 20-weeks of 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness
Time Frame: 20-weeks
|
via Pulse Wave Velocity
|
20-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic Blood Pressure
Time Frame: 20-weeks
|
systolic blood pressure
|
20-weeks
|
|
Pressure Wave Reflection
Time Frame: 20-weeks
|
via Augmentation Index
|
20-weeks
|
|
Muscular Strength
Time Frame: 20-weeks
|
via Hand Grip Dynamometer
|
20-weeks
|
|
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
Time Frame: 20-weeks
|
via Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test
|
20-weeks
|
|
Diastolic Blood Pressure
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
June 3, 2018
First Posted (Actual)
June 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 18, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SwimmingMenopause
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.