Exercise Impact in Elderly with Multimorbidity: HbA1c and Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension; Diabetes; Osteoarthritis; Depression Disorders; Multimorbidity; Respiratory Disorders; Sarcopenia in Elderly; Dyslipidemia; High Blood Cholesterol; Obese Patients

• Registration Number: NCT06879639
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-09
• Primary Completion: 2024-12-13
• Status Verified: 2025-01
• Study Completion: 2025-01-31
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Being elderly adult 60 years old
• Having grade 1 medicated hypertension (systolic blood pressure ≥ 140 and diastolic blood pressure ≥ 90) and 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
WHOQOL questionnaire	10 weeks	Quality of life will be measured using the WHOQOL questionnaire validated for the Portuguese language.
IPAQ questionnaire	10 weeks	The IPAQ questionnaire will measure each participant's level of physical activity.
Pittsburgh questionnaire	10 weeks	Sleep quality level will be measured using the Pittsburgh questionnaire
DASS 21	10 weeks	Depression, anxiety and stress will be measured using a scale given by the DASS 21 questionnaire.
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.

Trial Locations

Locations (1)

Municipal Pavilion of Vila Nova de Famalicão; 🇵🇹 Vila Nova De Famalicão, Braga, Portugal