Clinical trial NCT04058093: Evaluation of a Functional Training Program in Primary Health Care
Official title: VIVE Active: avaliação de um Programa de Treino Funcional Nos Cuidados de saúde primários - Estudo Quasi-experimental
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Exercise
Physical activity
Nutrition
Counselling
Primary health care
Lead sponsor: Unidade de Saude da Ilha de Sao Miguel
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in hand grip strength
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary outcomes:
measure: Adherence to the functional training program
timeFrame: Up to 6 months
measure: Perceived enjoyment
timeFrame: Up to 6 months
measure: Perceived exertion
timeFrame: Up to 6 months
measure: Participants' satisfaction
timeFrame: T1, Post-intervention (at month 6)
measure: Change in body mass index
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in waist circumference
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in body fat
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in body lean mass
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in systolic and diastolic blood pressure
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in fast blood glycemia
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in HbA1c
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in blood lipid profile
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in chronic pain
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in medication dependence
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in nicotine dependence
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in health-related quality of life
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in perceived stress
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in psychological distress
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in mental well-being
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Changes in eating habits
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Other outcomes:
Locations:
city: Ponta Delgada
country: Portugal
facility: Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
state: Azores
Study officials:
affiliation: Unidade de Saúde da Ilha de São Miguel
name: Sara B. Ponte, MD
role: PRINCIPAL_INVESTIGATOR
References: