Physical Activity Promotion in Primary Health Care Settings

Motor Activity Clinical Trial

Official title:

Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857127
• Other study ID #: FAPESP14/03909-2
• Status: Completed
• Phase: N/A
• First received: July 30, 2016
• Last updated: August 4, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area

Description:

There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering programs of physical activity becomes a convenient option to increase the physical activity level of the population and promote aging process more active and healthy over the life. There is need for greater depth in relation to the operation of programs to promote physical activity and the effects of these programs on different biopsychosocial aspects, especially those offered in primary care settings. This research aims to evaluate a walking program geared to adults and seniors on the following aspects:

1. Characteristics and operation of the intervention,

2. effects of behavior change to physical activity, and

3. biopsychosocial effects of physical activity.

It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and control group (n = 71). The intervention will last for six months, with a subsequent follow-up period of six months after the intervention. The program will offer supervised exercise twice a week, lasting an hour. The classes will consist of recreational activities, walking and educational strategies of behavior change for physical activity. Variables will be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over 40 years, low levels of education, income and varied biopsychosocial characteristics are expected. After the intervention, it is expected that the program present characteristics of low adhesion and retention, especially because of the barrier "lack of time". Still, the promotion of supervised walking increase levels of physical activity beyond the time provided by the program and it will improve the biopsychosocial conditions of the participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• To be insufficiently active

• To accept the intervention invitation

• Living around the selected primary health care

• To sign the Term os Consent

• To have 18 years or more

Exclusion Criteria:

• To participate only in one day of intervention

• To have less than 75% of presence in the intervention

• To give up of the intervention

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Motor Activity

Intervention

Behavioral:
• Walking program
To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.

Locations

Country	Name	City	State
Brazil	Secretaria Municipal de Saúde	São Carlos	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire	Physical activity level evaluated through the International Physical Activity Questionnaire	six months	Yes
Primary	Objective evaluation of physical activity level evaluated through accelerometer device	Physical activity level evaluated through accelerometer device	six months	Yes