NCT04743128

Brief Summary

Introduction: Atherosclerotic Peripheral Arterial Disease (PAD) is the leading cause of mortality in the western world. To maintain homeostasis of the vessel wall, vascular cells produce a high level of heat shock proteins (HSP), among which is Hsp70, to stimulate innate immunity and face stress. Methods: This is a clinical trial where 260 individuals were evaluated by a screening test employing the Ankle-Arm Index (ABI), 220 of them were not within risk value (0.91 to 0.99 mmHg). In the clinical trial, 32 individuals were included. A control group and an experimental group were formed. Aerobic exercise intervention was performed for 12 weeks. The level of Hsp70 was evaluated, physical and clinical measurements were applied at the beginning and at the end of the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

January 27, 2021

Last Update Submit

April 27, 2022

Conditions

Keywords

Peripheral Arterial DiseaseAerobic ExerciseHSP70

Outcome Measures

Primary Outcomes (1)

  • Impact of exercise on expression of Hsp70 in individuals at risk of peripheral arterial disease

    This is a clinical trial where 260 individuals were evaluated by a screening test employing the Ankle-Arm Index (ABI). A number of 220 individuals were not within risk value (0.91 to 0.99 mmHg). In the clinical trial, 32 individuals were included. A control group and an experimental group were formed. Aerobic exercise intervention was performed by the experimental group. The level of Hsp70 was evaluated, physical and clinical measurements were applied at the beginning and at the end of the trial.

    12 weeks

Study Arms (2)

Control group

NO INTERVENTION

The control group received written recommendations to exercise three times per week, for a period of 12 weeks but they did not attend the training sessions.

Exercise group

EXPERIMENTAL

The experimental group started an exercise program to achieve 65% to 80% of the maximum heart rate by using a pulsometer that measured the heart rate in order to get to the moderate intensity activity goal. The exercise session was 60 minutes long, three times per week, completing 180 minutes per week of moderate intensity exercise, for 12 weeks in total.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

The experimental group started an exercise program to achieve 65% to 80% of the maximum heart rate by using a pulsometer that measured the heart rate in order to get to the moderate intensity activity goal. The exercise session was 60 minutes long, three times per week, completing 180 minutes per week of moderate intensity exercise, for 12 weeks in total.

Exercise group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ABI cut point from 0.91 to 0.99
  • Age, from 40 to 75 years old
  • Both genders

You may not qualify if:

  • Unable to perform Bruce's stress test
  • Presence of fractures or sprains in the last 3 months
  • Diagnosis of diabetes, heart disease, angina pectoris or heart attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPAEP

Puebla City, 72410, Mexico

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Clara Luz Pérez Quiroga, MCs

    Universidad Popular Autónoma del Estado de Puebla

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 8, 2021

Study Start

June 3, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations