Sedentary LifestyleVIVEactiveNCT04058093
Evaluation of a Functional Training Program in Primary Health Care
A study testing Functional Training Program in people with Sedentary Lifestyle, run by Unidade de Saude da Ilha de Sao Miguel at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Functional Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary (<150 minutes of moderate-intensity PA per week or <75 minutes of vigorous-intensity PA) users of Health Center of Ponta Delgada.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Portugal1 site
Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
Ponta Delgada, Azores, 9500-354
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Functional Training Program
- Keywords
- Exercise, Physical activity, Nutrition, Counselling, Primary health care
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Up to 6 months
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).
Measured: Up to 6 months
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.
Measured: Up to 6 months
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).
Measured: T1, Post-intervention (at month 6)
Change in body mass index
Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in waist circumference
Waist circumference in centimeters.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body fat
Measured by bioelectrical impedance analysis.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body lean mass
Measured by bioelectrical impedance analysis.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in systolic and diastolic blood pressure
Resting systolic and diastolic blood pressure.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in fast blood glycemia
Fast blood glycemia (mg/dL).
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in HbA1c
HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in blood lipid profile
Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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'.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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).
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade de Saude da Ilha de Sao Miguel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara B. Ponte, Unidade de Saude da Ilha de Sao Miguel
- Investigators
- Sara B. Ponte, MD, Principal investigator, Unidade de Saúde da Ilha de São Miguel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058093
- Sponsor's protocol ID
- USISM_01_19
- Acronym
- VIVEactive
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVE Active: avaliação de um Programa de Treino Funcional Nos Cuidados de saúde primários - Estudo Quasi-experimental
- ClinicalTrials.gov ID
- NCT04058093
- Acronym / sponsor ID
- VIVEactive / USISM_01_19
- Conditions
- Sedentary Lifestyle
- Keywords
- Exercise, Physical activity, Nutrition, Counselling, Primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unidade de Saude da Ilha de Sao MiguelUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Training Program | Experimental | Behavioral: Functional Training ProgramFunctional 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedentary (<150 minutes of moderate-intensity PA per week or <75 minutes of vigorous-intensity PA) users of Health Center of Ponta Delgada.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Training ProgramFunctional 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. | Behavioural | Functional Training Program |
Primary outcome
Change in hand grip strength
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
20 secondary outcomes
Adherence to the functional training program
Time frame: Up to 6 months
Perceived enjoyment
Time frame: Up to 6 months
Perceived exertion
Time frame: Up to 6 months
Participants' satisfaction
Time frame: T1, Post-intervention (at month 6)
Change in body mass index
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in waist circumference
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body fat
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body lean mass
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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)
Change in fast blood glycemia
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in HbA1c
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in blood lipid profile
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in chronic pain
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in medication dependence
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in nicotine dependence
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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)
Change in perceived stress
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in psychological distress
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in mental well-being
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Changes in eating habits
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara B. Ponte, MD principal investigator
Unidade de Saúde da Ilha de São Miguel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Training Program in people with Sedentary Lifestyle, run by Unidade de Saude da Ilha de Sao Miguel at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara B. Ponte, MD (+351 296 960 286, Sara.CB.Ponte@azores.gov.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand grip strength (time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.