NCT02976506

Brief Summary

To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 14, 2016

Last Update Submit

November 23, 2016

Conditions

ElderlyHypertensionPhysical Conditioning

Outcome Measures

Primary Outcomes (1)

  • Lower Blood Pressure and or keeping it under control

    12 weeks

Secondary Outcomes (3)

  • Improve Cardiorespiratory fitness.

    12 weeks

  • Improve abdominal strength.

    12 weeks

  • Quality of life

    12 weeks

Study Arms (2)

Unsupervised exercise program

EXPERIMENTAL

To verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group

Behavioral: Unsupervised exercise program

Physical fitness and quality of life

EXPERIMENTAL

To verify the interference of a walking program on physical fitness and quality of life.

Behavioral: Physical fitness and quality of life

Interventions

Unsupervised exercise programBEHAVIORAL

Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to \< 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.

Also known as: interference on blood pressure
Unsupervised exercise program
Physical fitness and quality of lifeBEHAVIORAL

Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to \< 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.

Physical fitness and quality of life

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or more, stable BP on the last three months, no changes on pharmacological treatment over the last six months and a sedentary behavior (non-participation in any kind of physical activity for at least 2 months).

You may not qualify if:

  • uncontrolled diabetes
  • congestive heart failure
  • acute myocardial infarction in the last six months
  • stroke in the last six months or under rehabilitation
  • previously diagnosed chronic renal failure
  • acute infectious diseases
  • recent systemic or pulmonary embolism
  • pulmonary hypertension
  • BP higher than 159 x 99 mmHg
  • neuromuscular
  • musculoskeletal or articular disorders diagnosed and not treated
  • clinical evaluation restraining PA
  • any situation preventing the patient from walk. Those criteria were verified in patients' medical charts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension League

Goiânia, Goiás, 74000, Brazil

Location

MeSH Terms

Conditions

HypertensionMotor Activity

Interventions

Physical FitnessQuality of Life

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealthPopulation CharacteristicsHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 29, 2016

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

BR(1)