NCT03546270

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

November 18, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

May 22, 2018

Results QC Date

March 27, 2019

Last Update Submit

October 30, 2020

Conditions

Keywords

SwimmingArterial StiffnessBlood PressureMuscular StrengthCardiorespiratory Endurance

Outcome Measures

Primary Outcomes (1)

  • Arterial Stiffness

    via Pulse Wave Velocity

    20-weeks

Secondary Outcomes (5)

  • Systolic Blood Pressure

    20-weeks

  • Pressure Wave Reflection

    20-weeks

  • Muscular Strength

    20-weeks

  • Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)

    20-weeks

  • Diastolic Blood Pressure

    20 weeks

Study Arms (2)

Swimming

EXPERIMENTAL

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

Control

NO INTERVENTION

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

SwimmingBEHAVIORAL

This group completed 20-weeks of swimming

Swimming

Eligibility Criteria

Age65 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Interventions

Swimming

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Dr. Song-Young Park
Organization
The University of Nebraska at Omaha

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 6, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

November 18, 2020

Results First Posted

August 5, 2019

Record last verified: 2020-10