Evaluation of a Functional Training Program in Primary Health Care

Sedentary Lifestyle Clinical Trial

— VIVEactive  

Official title:

VIVE Active: avaliação de um Programa de Treino Funcional Nos Cuidados de saúde primários - Estudo Quasi-experimental

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04058093
• Other study ID #: USISM_01_19
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: September 2021

Study information

• Verified date: October 2019
• Source: Unidade de Saude da Ilha de Sao Miguel
• Contact: Sara B. Ponte, MD
• Phone: +351 296 960 286
• Email: Sara.CB.Ponte[@]azores.gov.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Functional Training Program
Functional training program (FTP) include: Functional training sessions will be oriented by graduates or masters in sport with the supervision of a sports medicine doctor; Group nutrition counseling, in the form of healthy cooking classes direct by nutritionists with the support of culinary students.

Locations

Country	Name	City	State
Portugal	Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)	Ponta Delgada	Azores

Sponsors (1)

Lead Sponsor	Collaborator
Unidade de Saude da Ilha de Sao Miguel

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to the functional training program	Proportion of adherence to the functional training program will be calculated by the average of adherence of each participant. The adherence of each participant will be quantified by the relationship between the sessions attended and the total number of sessions scheduled over the 6 months.; Participants' satisfaction levels will be measured by 10-items questionnaire, on a five point Likert scale from 1 (displeased) to 5 (very satisfied).	Up to 6 months
Secondary	Perceived enjoyment	Perceived enjoyment of the functional training program will be measured biweekly by a scale rated from 1 (very unpleasant) to 5 (very enjoyable).	Up to 6 months
Secondary	Perceived exertion	Perception exertion the functional training program will be measured biweekly by the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.	Up to 6 months
Secondary	Participants' satisfaction	Participant's satisfaction levels will be measured by 10-items questionnaire, on a five point Likert scale from 1 (displeased) to 5 (very satisfied).	T1, Post-intervention (at month 6)
Secondary	Change in body mass index	Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in waist circumference	Waist circumference in centimeters.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in body fat	Measured by bioelectrical impedance analysis.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in body lean mass	Measured by bioelectrical impedance analysis.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in systolic and diastolic blood pressure	Resting systolic and diastolic blood pressure.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in fast blood glycemia	Fast blood glycemia (mg/dL).	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in HbA1c	HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in blood lipid profile	Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in chronic pain	Brief Pain Inventory (BPI) will assess the average pain at rest, using a numerical (0-10) rating scale on the BPI Short Form. A higher score indicates worse pain (10 is "worst pain imaginable") and zero indicates 'no pain at all'.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in medication dependence	Number of pills ingested per day (includes antihypertensives, oral antidiabetics, insulin (injected units), analgesics, anti-inflammatory drugs, psychotropic drugs and antidyslipidemic).	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in nicotine dependence	Fagerström Test for Nicotine Dependence (FTND) will be applied only in smokers participants.; FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in health-related quality of life	The health-related quality of life questionaire EQ-5D-5L is a standardised self-report measure of health status developed by the EuroQol Group. It consists of the descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions, namely mobility, self care, usual activities, pain/discomfort, anxiety/depression.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in perceived stress	Perceived Stress Scale (PSS 10), validated for portuguese population, is a self-report scale with 10 items on daily hassles and the current feeling of being able to handle problems that need to be addressed. It is a five-point Likert scale ranging from 0 (never) to 4 (very often). This questionnaire is widely used to measure perceived stress and has adequate internal and test-retest reliability.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in psychological distress	Depression, anxiety stress scale-21 (DASS-21) consists of three 7-item subscales: depression, anxiety, and stress. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). This scale has good psychometric properties in both clinical and non-clinical samples. Also, this scale reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation) and depression (low mood/anhedonia), which are highly comorbid.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Change in mental well-being	Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale, validated and self-report instrument used to assess mental wellbeing in general population. Possible scores range from range from 14-70, with higher scores indicating higher mental well-being.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary	Changes in eating habits	PREDIMED (PREvención con DIeta MEDiterránea) is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.	T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)