Essential (primary) hypertension
Conditions
Interventions
This is a pragmatic multicenter parallel randomized clinical trial conducted in three municipalities of the state of Santa Catarina Brazil namely Brusque Criciuma and Sao Jose with blinded outcome ass
Sponsors
Universidade Federal de Santa Catarina
Secretária de Saúde de Brusque
Secretária Municipal de Saúde de Criciúma
Universidade do Extremo Sul Catarinense
Secretaria Municipal Saúde São José
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Men and women aged 50 years or older; diagnosis of hypertension or type 2 diabetes mellitus or dyslipidemia confirmed by medical records; not meeting population recommendations for physical activity defined as less than 150 minutes of moderate physical activity per week or equivalent; registered and under follow up in Primary Health Care in the participating municipality
Exclusion criteria
Exclusion criteria: Clinical conditions that prevent the safe practice of physical exercise identified by medical evaluation; severe cognitive impairment that hinders the understanding and execution of exercises; participation in another structured regular physical exercise program in the previous three months; refusal to sign the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate participant engagement in the intervention through the adherence rate defined as the proportion of participants who complete the twelve weeks of intervention and the attendance rate defined as the average frequency of presence at sessions during the twelve weeks calculating the Composite Participation Index corresponding to the arithmetic mean between adherence and attendance verified through attendance records completed at each session in all Primary Health Care Units and expressed as a percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the participants quality of life assessed using the validated World Health Organization Quality of Life Bref (WHOQOL Bref) questionnaire applied before and after the intervention considering physical mental and social well being dimensions the total and domain scores will be analyzed expecting to observe an average increase equal to or greater than ten percent compared to baseline ;To evaluate the presence and intensity of depressive symptoms assessed using the Patient Health Questionnaire 9 (PHQ 9) applied before and after the intervention the total score ranging from zero to twenty seven points will be used for classification expecting to observe an average reduction equal to or greater than two points or a change in clinical category compared to the initial value ;To identify barriers and facilitators to regular physical exercise practice through interviews focus groups and the personal barriers to physical activity questionnaire proposed by Reichert in two thousand and eleven applied before and after the intervention responses will be categorized and the frequency of each reported barrier and facilitator will be calculated expecting to observe a reduction in reported barriers and an increase in facilitators at the end of the program ;To evaluate functional performance using validated tests applied before and after the intervention including dynamic balance and agility assessed by the Timed Up and Go Test TUG at maximal and habitual speeds recording the shortest time of three attempts lower limb strength and endurance assessed by the thirty second Chair Stand Test with muscle power calculated using the equation proposed by Alcazar and colleagues in two thousand and eighteen upper limb strength and endurance assessed by handgrip strength using a digital dynamometer and by the thirty second Arm Curl Test flexibility assessed by the Sit and Reach Test considering the greatest distance of three attempts and aerobic capacity assessed by the Six Minute | — |
Countries
BR
Contacts
Public ContactJoão Oliveira Junior
Universidade Federal de Santa Catarina
Outcome results
None listed