- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058093
Evaluation of a Functional Training Program in Primary Health Care (VIVEactive)
VIVE Active: avaliação de um Programa de Treino Funcional Nos Cuidados de saúde primários - Estudo Quasi-experimental
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Azores
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Ponta Delgada, Azores, Portugal, 9500-354
- Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional Training Program
Functional training program (FTP) will last for 6 months and will include:
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Functional training program (FTP) include:
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No Intervention: Waiting list control group
Participants will not participate in any specific intervention, but will receive the FTP after the experimental period (6 months).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hand grip strength
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the functional training program
Time Frame: Up to 6 months
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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
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Perceived enjoyment
Time Frame: Up to 6 months
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Perceived enjoyment of the functional training program will be measured biweekly by a scale rated from 1 (very unpleasant) to 5 (very enjoyable).
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Up to 6 months
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Perceived exertion
Time Frame: Up to 6 months
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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.
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Up to 6 months
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Participants' satisfaction
Time Frame: T1, Post-intervention (at month 6)
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Participant's satisfaction levels will be measured by 10-items questionnaire, on a five point Likert scale from 1 (displeased) to 5 (very satisfied).
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T1, Post-intervention (at month 6)
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Change in body mass index
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in waist circumference
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Waist circumference in centimeters.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in body fat
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Measured by bioelectrical impedance analysis.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in body lean mass
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Measured by bioelectrical impedance analysis.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in systolic and diastolic blood pressure
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Resting systolic and diastolic blood pressure.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in fast blood glycemia
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Fast blood glycemia (mg/dL).
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in HbA1c
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in blood lipid profile
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in chronic pain
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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'.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in medication dependence
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Number of pills ingested per day (includes antihypertensives, oral antidiabetics, insulin (injected units), analgesics, anti-inflammatory drugs, psychotropic drugs and antidyslipidemic).
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in nicotine dependence
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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)
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Change in health-related quality of life
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in perceived stress
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in psychological distress
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Change in mental well-being
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Changes in eating habits
Time Frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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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.
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T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Collaborators and Investigators
Investigators
- Principal Investigator: Sara B. Ponte, MD, Unidade de Saúde da Ilha de São Miguel
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USISM_01_19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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