NCT04862754

Brief Summary

this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 12, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

January 12, 2021

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Central arterial stiffness measurements (Pulse Wave Velocity [PWV], augmentation index )

    Pulse wave analysis (PWA) of the women in the two groups: pre and post treatment for pulse wave velocity (PWV) and augmentation index(AIx) Pulse Wave Velocity \[PWV\], augmentation index (AIx @75HR) and resting heart rate were measured using analysis equipment which called Non-invasive blood pressure measurement system using "Mobil-O-Graph 24h PWA " with Hypertension Management Software Client Server (HMS-CS 4.3). PWA was performed using an oscillometric Mobil-O-Graph R 24 h PWA Monitor device (I.E.M GmbH, Germany) with integrated ARCSolver® software

    two months

Secondary Outcomes (3)

  • blood lipid profile

    two months

  • interleukin 6

    two months

  • blood pressure (systolic and diastolic)

    two months

Study Arms (2)

interval training

EXPERIMENTAL

Aerobic interval training. It consisted of a modified interval cycle ergometer training program (3 days a week for 8 weeks). AIT consisted of 8 min warm up, followed by four times of 4-min intervals with HR at 80% of submaximal predetermined HR, with active phases of 3 min of cycling at 60% of submaximal predetermined HR. The exercise session was terminated by 5 min cool down

Other: interval training exercise

medical treatment

NO INTERVENTION

hypertensive medication

Interventions

interval training exercise

interval training

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • physically inactive
  • BMI 30-40
  • Stage 1 and 2 hypertension
  • Elevated BP as systolic BP ≥130 mm Hg and/or diastolic BP ≥85 mm Hg measured at the brachial artery.

You may not qualify if:

  • Medications known to affect weight or appetite
  • Any disease associated with exercise intolerance.
  • Women were taking hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, 17452, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cairo University

Study Record Dates

First Submitted

January 12, 2021

First Posted

April 28, 2021

Study Start

January 25, 2021

Primary Completion

March 30, 2021

Study Completion

April 15, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations