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Evaluation of a Functional Training Program in Primary Health Care (VIVEactive)

U

Unidade de Saude da Ilha de Sao Miguel

Status

Unknown

Conditions

Sedentary Lifestyle

Treatments

Behavioral: Functional Training Program

Study type

Interventional

Funder types

Other

Identifiers

NCT04058093
USISM_01_19

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Functional Training Program
Experimental group
Description:
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).
Treatment:
Behavioral: Functional Training Program
Waiting list control group
No Intervention group
Description:
Participants will not participate in any specific intervention, but will receive the FTP after the experimental period (6 months).

Trial contacts and locations

1

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Central trial contact

Sara B. Ponte, MD

Data sourced from clinicaltrials.gov

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