An interventional study of Functional Training Program in Sedentary Lifestyle, sponsored by Unidade de Saude da Ilha de Sao Miguel. Status unknown at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Unidade de Saude da Ilha de Sao Miguel · Not applicable, Interventional, and Prevention
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.
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.
Unidade de Saude da Ilha de Sao Miguel is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will not participate in any specific intervention, but will receive the FTP after the experimental period (6 months).
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.
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.
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Resting 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
Fast blood glycemia (mg/dL).
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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).
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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Unidade de Saude da Ilha de Sao Miguel