Depression Disorders, Diabetes, Dyslipidemia, High Blood Cholesterol, Hypertension, Multimorbidity, Obese Patients, Osteoarthritis, Respiratory Disorders, Sarcopenia in Elderly
Conditions
Keywords
Multimorbidity, Diabetes, High blood pressure, Older people, Combined exercise, Aquatic exercise
Brief summary
The main objective of the study is to compare the effect of two different types of physical exercise modalities on glycated hemoglobin and blood pressure in elderly individuals with multimorbidity. The main characteristic of the proposal is that it is experimental, with two intervention groups with physical exercise that will be randomized in the order of participation of the groups and forwarded to the researchers regarding the evaluations and training periods. In addition, the study will be controlled, as it has a control group that will not perform any intervention with physical exercises during the study period. To allocate the participants in each exercise group and for the control group, the researchers will use the 1:1 method, the user will receive an automatic generator through the random.org website. The main questions raised by the studies will be: Is land-based training more effective than aquatic training for this population in improving the primary outcomes? Is there a difference between training at these intensities and not doing any physical exercise in this population with these primary outcomes? Participants in the 2 intervention groups will: Train 3x per week for 10 weeks at intensities that will progress over the weeks.
Interventions
OTHERExercise
The workout routine for the Land Exercise (LE) group will be segmented as follows: A cardio segment (15-20 minutes) involving treadmill walking/running or cycling on the stationary bike; A strength training segment (35 minutes) comprising bench press, seated row, leg extension, squats, pull down, peck-deck, hamstring curls, curl-ups, and back extensions; and a cool-down phase (5-10 minutes) featuring stretching exercises.
OTHERControl
The control group will not receive any formal indication or support to perform structured exercise training but will be allowed to engage in physical activity ad libitum.
Sponsors
Universidade do Porto
Foundation for Science and Technology, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being elderly adult 60 years old * Having grade 1 medicated hypertension (systolic blood pressure ≥ 140 and diastolic blood pressure ≥ 90) or having type 2 diabetes mellitus * Volunteers may have other morbidities such as: anxiety/depression, knee osteoarthritis or obesity * Be fit for the practice of physical activity
Exclusion criteria
* Being a smoker * Have severe musculoskeletal problems that prevent you from carrying out physical activities * Unable to carry out the protocol completely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (Hb1Ac) | 10 weeks | In the pre- and post-training moments during the morning and fasting period, venous blood samples will be collected to analyze the glycemic profile. The outcome measure will be expressed as a percentage (%), representing the average blood glucose level over the last 2 to 3 months. |
| Blood pressure | 10 weeks | Office blood pressure (OBP) will be evaluated and monitored during pre-training moments using automatic monitors, and Home Blood Pressure Monitoring (HBPM) will be conducted with appropriate collection devices according to the 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement.The results of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) will be shown in millimeters of mercury (mmHg) for OBP and HBPM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | 10 weeks | Heart rate will be monitored through a heart rate monitor (POLAR® HR monitor model RS800cx (recording frequency: 1000Hz), consequently obtaining heart rate variability, and such collection will take place in a sitting position with spontaneous breathing, for 20 minutes at total rest at the appropriated local |
| Lipid Profile (LDL, HDL, VLDL and Triglycerides) | 10 weeks | In the pre- and post-training moments during the morning and fasting period, venous blood samples will be collected to analyze the lipid (LDL; HDL; VLDL; triglycerides and total cholesterol). The unit of measurement used to express the results will be mg/dL. |
| Body Mass Index (BMI) | 10 weeks | The participants' body mass and height will be measured using bioimpedance and a stadiometer, respectively. Thus, researchers will have access to the BMI weight (kg)/height (m2). |
| Fasting glucose | 10 weeks | In the pre- and post-training moments during the morning and fasting period, venous blood samples will be collected to analyze the glycemic profile by fasting glucose (mg/dL). |
| Agility | 10 weeks | Agility and mobility will be assessed with the Timed up and go test. All testing protocol will be followed and results will be displayed as per guidelines. |
| Cardiorespiratory fitness | 10 weeks | The 6-minute walk test will be performed to measure the cardiorespiratory capacity of the elderly. It will be carried out according to the proposed guidelines |
| Hand grip strength | 10 weeks | The handgrip strength test will be performed with a calibrated device and the test protocol will be guided by official guidelines. |
| Sit and stand test | 10 weeks | The test will measure the strength of the lower limbs of elderly people and will be guided by official guidelines |
| World Health Organization Quality of Life - WHOQOL questionnaire | 10 weeks | Quality of life will be measured using the World Health Organization Quality of Life - WHOQOL questionnaire validated for the Portuguese language.The WHOQOL uses a scoring system ranging from 1 to 5, with responses varying according to the intensity, frequency, or severity of each item. The instrument is structured into four primary domains and includes several supplementary items. In the summation, the score ranges from a minimum of 4, indicating poor quality of life, to a maximum of 20, reflecting a good quality of life. |
| Internation Physical Activity - IPAQ questionnaire | 10 weeks | The Internation Physical Activity - IPAQ questionnaire will measure each participant's level of physical activity. It includes items regarding the frequency, duration, and intensity of physical activity undertaken in the previous week. The summation of responses results in a total score that is categorized into low, moderate, or high levels of physical activity. Higher scores indicate greater physical activity, which correlates with enhanced physical fitness and overall health. |
| Pittsburgh Sleep Quality Index - PSQIquestionnaire | 10 weeks | Sleep quality level will be measured using the Pittsburgh Sleep Quality Index -PSQI questionnaire. The questionnaire consists of 19 items that cover various dimensions of sleep, including sleep latency, duration, disturbances, efficiency, and medication use. These items are grouped into seven component scores, which are aggregated to derive a global score. The total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 typically indicates significant sleep disturbances, while lower scores reflect better sleep quality. |
| Depression, Anxiety, and Stress Scale - DASS 21 | 10 weeks | Depression, anxiety and stress will be measured using a scale given by the Depression, Anxiety, and Stress Scale - DASS 21 questionnaire. The scale is composed of 21 items, divided into three subscales: depression, anxiety, and stress, each consisting of 7 items. Participants rate each item on a 4-point Likert scale, ranging from 0 (not at all) to 3 (very much or most of the time), reflecting the frequency of symptoms experienced during the previous week. Subscale scores are computed by summing the item responses within each subscale. Higher scores indicate greater severity of depression, anxiety, or stress. The resulting scores are classified into severity levels, ranging from normal to extremely severe. |
| Balance test | 10 weeks | Balance will be analyzed through a biomechanical assessment with a force platform for each volunteer. |
| Muscle electrical activity | 10 weeks | The electrical activity of the vastus medialis and lateralis muscles will be assessed with surface electromyography electrodes. |
Countries
Portugal
Contacts
PRINCIPAL_INVESTIGATORDaniel M Gonçalves, Professor
Universidade do Porto
PRINCIPAL_INVESTIGATORVictor Hugo V Carrijo, MsC. Physioterapy
Universidade do Porto
PRINCIPAL_INVESTIGATORMario Jorge O Costa, Professor
Universidade do Porto
Outcome results
None listed