NCT02778568

Brief Summary

The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

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 not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 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

Study Start

First participant enrolled

January 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

December 12, 2013

Last Update Submit

May 23, 2016

Conditions

Peripheral Artery DiseaseIntermittent Claudication

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    Change from baseline to 12 and 24 weeks

Secondary Outcomes (8)

  • Change in Walking distance

    Change from baseline to 12 and 24 weeks

  • Change in Health related Quality of life

    Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks

  • Change in Muscle blood flow of limbs

    Change from baseline to 12 and 24 weeks

  • Change in body fat

    Change from baseline to 12 and 24 weeks

  • Change Serum Cholesterol

    Change from baseline to 12 and 24 weeks

  • +3 more secondary outcomes

Study Arms (2)

Resistance Training

EXPERIMENTAL

Patients performed resistance exercises

Behavioral: Resistance training

Control

ACTIVE COMPARATOR

Patients who performed flexibility exercise

Behavioral: Control

Interventions

Resistance trainingBEHAVIORAL

Resistance training exercises

Also known as: Physical training
Resistance Training
ControlBEHAVIORAL

Stretching exercises

Control

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had a graded treadmill test that was limited by claudication (2 minutes)
  • Had an ankle brachial index \<0.90
  • Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
  • Were not performing any regular exercise program
  • Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
  • Were nonobese
  • Individuals who have not undergone bypass surgery or angioplasty least one year ago

You may not qualify if:

  • Had no symptoms related to myocardial ischemia during the treadmill test
  • Amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Hospital of Pernambuco - PROCAPE

Recife, Pernambuco, 50100-060, Brazil

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Resistance TrainingPhysical Conditioning, Human

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marilia A Correia, MS

    University of Pernambuco

    STUDY CHAIR

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
Full Professor

Study Record Dates

First Submitted

December 12, 2013

First Posted

May 20, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

May 25, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)