Evaluation of a Functional Training Program in Primary Health Care

NCT ID: NCT04058093

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-09-30

Brief Summary

Sedentarism is the fourth risk factor for worldwide mortality and morbility. Considering the high prevalence of sedentarism (57.0%) and obesity (30.5%) in Azores islands (Portugal), local primary health care (PHC) services should support the implementation of complementary interventions and the development of medical research in the area of active lifestyle promotion.

This study aims to evaluate the feasibility and effectiveness of a 6-months functional training program (FTP), which includes a group nutrition counseling, in sedentary users of Ponta Delgada Health Center (PDHC), compared to a waiting list control.

Detailed Description

This work will be a prospective, longitudinal, quasi-experimental study, with an experimental and a waiting list control group. Here, the investigators aim to test the feasibility and effectiveness of a 6-months functional training program in sedentary users of PDHC. The recruitment of participants will be held in PDHC by health professionals (e.g., family medicine doctors, nurses, nutritionists, psychologists, etc). Participants will be allocated into two groups (experimental and waiting list control groups). After signed informed consent and baseline measures, experimental group will conduct a 6-months functional training program (FTP), which comprises functional training sessions and group nutrition counseling. In every session, it will be evaluated the participants' adherence and theirs perceived enjoyment and exertion. The other outcomes (primary and secondary) will be analyzed through a face-to-face contact, in three different moments: baseline (T0), post-intervention (at month 6, T1) and 6-month follow-up (at month 12, T2). The control group will not participate in any specific intervention, but will receive the FTP after the experimental period. An intention-to-treat and per protocol analysis will be performed to analyze intervention effectiveness and efficacy.

Conditions

Sedentary Lifestyle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Functional Training Program

Functional training program (FTP) will last for 6 months and will include:

1. Functional training sessions (each 45-minutes long, twice a week);

2. Group nutrition counseling (each 90-minutes long, in three different moments throughout the intervention: week 1, 12 and 20).

Group Type: EXPERIMENTAL

Functional Training Program

Intervention Type: BEHAVIORAL

Functional training program (FTP) include:

1. Functional training sessions will be oriented by graduates or masters in sport with the supervision of a sports medicine doctor;

2. Group nutrition counseling, in the form of healthy cooking classes direct by nutritionists with the support of culinary students.

Waiting list control group

Participants will not participate in any specific intervention, but will receive the FTP after the experimental period (6 months).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Functional Training Program

Functional training program (FTP) include:

1. Functional training sessions will be oriented by graduates or masters in sport with the supervision of a sports medicine doctor;

2. Group nutrition counseling, in the form of healthy cooking classes direct by nutritionists with the support of culinary students.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Sedentary (<150 minutes of moderate-intensity PA per week or <75 minutes of vigorous-intensity PA) users of Health Center of Ponta Delgada.

Exclusion Criteria

• Users with a medical contraindications to moderate-to-vigorous intensity physical activity, such as: unstable angina; deep vein thrombosis; recent thromboembolism or embolism; acute systemic infection or fever; atrioventricular block of 2nd grade or higher (without pacemaker); negative deflection of the ST segment deflection of the ST segment > 2 mm; severe neuro-musculoskeletal dysfunction; severe mitral or aortic insufficiency or stenosis without adequate treatment; decompensated heart failure; resting heart rate above 100 bpm; other decompensated metabolic disorders; pericarditis or acute myocarditis; uncontrolled arrhythmia; uncontrolled resting hypertension (SBP ≥ 180 or DBP ≥ 110); orthostatic hypotension with a fall in SBP> 20 mmHg or uncontrolled diabetes.
• Users with physical and/or mental disabilities or
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidade de Saude da Ilha de Sao Miguel

OTHER

Sponsor Role: lead

Responsible Party

Sara B. Ponte

MD, General Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara B. Ponte, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade de Saúde da Ilha de São Miguel

Locations

Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)

Ponta Delgada, Azores, Portugal

Countries

Portugal

Central Contacts

Sara B. Ponte, MD

Role: CONTACT

Sara.CB.Ponte@azores.gov.pt

+351 296 960 286

Other Identifiers

USISM_01_19

Identifier Type: -

Identifier Source: org_study_id