Effects of Physical Activity on Cardiovascular Risk and Quality of Life

NCT ID: NCT02767739

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Community intervention trial, randomized, to promote regular PA and social and cultural support activities for 9 months in older-adult primary care users and assess their effects on cardiovascular risk factors and health-related quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A structured program to promote Physical , according to the recommended guidelines and supervised by healthcare personnel should be deployed to assess their short, medium and long-term effects on CVD risk and Qulity of life. The aim of this study was to evaluate the effectiveness of a program to promote Physical, social and cultural activities for 9 months on cardiovascular risk factors and quality of life among older-adults,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical, social and cultural activities

Physical Activity: The training program will be supervised by a physical activity specialist and will consiste of two aerobic exercise sessions per week, including walking and stretching exercises after walking. Each session will be 60 minutes and the size of groups will be from 15 to 30 participants. Additionally, participants will receive advice about the health benefits of PA and PHC nurses using different strategies to encourage the adherence of participants to the program.

Social and cultural support activities. Activities will include: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons. These activities will be performed once a month.

Group Type EXPERIMENTAL

Physical, social and cultural activities

Intervention Type BEHAVIORAL

This intervention included two 60-min aerobic exercise sessions per week. Each session was supervised by a physical activity specialist and walking and stretching exercises were performed after programmed exercise sessions. PHC nurses were prepared to advise patients about the health benefits of PA and used different strategies to encourage the adherence of participants to the program. In addition, social and cultural support activities were included in this intervention program. These activities were performed once a month and they included: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons.

Control Group

No intervention. We will measure the variables at the begining and after 9 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical, social and cultural activities

This intervention included two 60-min aerobic exercise sessions per week. Each session was supervised by a physical activity specialist and walking and stretching exercises were performed after programmed exercise sessions. PHC nurses were prepared to advise patients about the health benefits of PA and used different strategies to encourage the adherence of participants to the program. In addition, social and cultural support activities were included in this intervention program. These activities were performed once a month and they included: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\* Adults users of 4 Primary Health Care Centers in Catalunya.

Exclusion Criteria

* Previous episode of ischemic heart disease (\<6 months).
* Outbreak of arthritis with limited ability to ambulate.
* Lung or heart disease with dyspnea mild-moderate efforts.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Victoria Arija Val

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Arija V, Villalobos F, Pedret R, Vinuesa A, Jovani D, Pascual G, Basora J. Physical activity, cardiovascular health, quality of life and blood pressure control in hypertensive subjects: randomized clinical trial. Health Qual Life Outcomes. 2018 Sep 14;16(1):184. doi: 10.1186/s12955-018-1008-6.

Reference Type DERIVED
PMID: 30217193 (View on PubMed)

Arija V, Villalobos F, Pedret R, Vinuesa A, Timon M, Basora T, Aguas D, Basora J; Pas-a-Pas research group. Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the "Pas-a-Pas" community intervention trial. BMC Public Health. 2017 Jun 15;17(1):576. doi: 10.1186/s12889-017-4485-3.

Reference Type DERIVED
PMID: 28619115 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P11/67

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.