NCT04396405

Brief Summary

The investigators aim to investigate the factors affecting cardiorespiratory fitness in individuals with systemic hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

May 8, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

May 8, 2020

Last Update Submit

July 1, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Exercise Capacity

    Exercise capacity assesment with six minute stepper test

    1 year

  • Submaximal Exercise Capacity

    Exercise capacity assesment with six minute walk test

    1 year

Secondary Outcomes (5)

  • Quality of Life assesment

    1 year

  • Arterial Stiffness

    1 year

  • Medication Adherence

    1 year

  • Physical Activity

    1 year

  • Ventricular functions ve ventricular structure

    1 year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stable hypertension patients between the ages of 18-65, who are in accordance with the criteria for inclusion in the clinical condition of Hacettepe University Faculty of Medicine, Department of Cardiology and Department of Nephrology from Hacettepe University Faculty of Medicine, Department of Internal Diseases, are included in the study. and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be include in the study.

You may qualify if:

  • Being 18 or older,
  • Having been diagnosed with primary or secondary hypertension,
  • Volunteering to participate in the study,

You may not qualify if:

  • Has a neurological, cognitive or orthopedic disease that will affect the measurements, Having severe respiratory disease (FEV1 \<35%; FVC \<50%),
  • Presence of acute infection,
  • Malignancy
  • Dementia,
  • Having hormone replacement therapy,
  • Have had any cardiovascular events in the last 6 months,
  • Body mass index is more than 40 kg / cm2,
  • Ejection fraction less than 50%,
  • Uncontrolled hypertension, diabetes,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionMuscle Weakness

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • EBRU CALIK-KUTUKCU, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • LALE TOKGOZOGLU, MD

    Hacettepe University

    STUDY CHAIR
  • YUSUF ZIYA SENER, MD

    Hacettepe University

    STUDY CHAIR
  • TOLGA YILDIRIM, MD

    Hacettepe University

    STUDY CHAIR
  • JABRAYİL JABRAYİLOV, MD

    Hacettepe University

    STUDY CHAIR
  • BEYZA NUR KARADUZ, MsC

    Hacettepe University

    STUDY CHAIR
  • BURCU OZCAN, MsC

    Hacettepe University

    STUDY CHAIR
  • DENİZ INAL-INCE, PhD

    Hacettepe University

    STUDY CHAIR
  • MELDA SAGLAM, PhD

    Hacettepe University

    STUDY CHAIR
  • NACİYE VARDAR-YAGLI, PhD

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 20, 2020

Study Start

January 15, 2021

Primary Completion

August 31, 2021

Study Completion

October 30, 2021

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations