Evaluation of a Functional Training Program in Primary Health Care

NCT04058093 | Unknown

• 1 other identifier: USISM_01_19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle

Keywords

Exercise; Physical activity; Nutrition; Counselling; Primary health care

Outcome Measures

Primary Outcomes (1)

• Change in hand grip strength

  Hand grip strength will be evaluated while the participant is in a sitting position with shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral and wrist between 0 and 30° of extension. The test will be repeated 3 times with the dominant hand, and maximum reading will be taken.

  T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)

Secondary Outcomes (20)

• Adherence to the functional training program

  Up to 6 months

• Perceived enjoyment

  Up to 6 months

• Perceived exertion

  Up to 6 months

• Participants' satisfaction

  T1, Post-intervention (at month 6)

• Change in body mass index

  T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)

Study Arms (2)

Functional Training Program

EXPERIMENTAL

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).

Behavioral: Functional Training Program

Waiting list control group

NO INTERVENTION

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

Interventions

Functional Training Program 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.

Functional Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidade de Saude da Ilha de Sao Miguel: lead

Study Sites (1)

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

Ponta Delgada, Azores, 9500-354, Portugal

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sara B. Ponte, MD

  Unidade de Saúde da Ilha de São Miguel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara B. Ponte, MD

CONTACT

+351 296 960 286; Sara.CB.Ponte@azores.gov.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, General Practitioner

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 15, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2021
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

PT (1)