Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure

May 25, 2026 updated by: Universidade do Porto

The Effect of 10 Weeks of Physical Exercise on Glycated Hemoglobin and Blood Pressure in Elderly People With Multimorbidity Conditions: a Controlled and Randomized Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Braga District
      • Vila Nova de Famalicão, Braga District, Portugal, 4760-104
        • Municipal Pavilion of Vila Nova de Famalicão

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combined physical exercise in land
Combined physical exercise performed in gym 3 times per week
Other: Exercise
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.
Other Names:
  • Physical exercise
  • Combined exercise
Other: Exercise
The activities for the Water Exercise (WE) group will be divided into segments: An aerobic portion (15-20 minutes) involving water walking and jogging combined with arm movements; A resistance portion (35 minutes) including chest/upper back guidance, chest back press, behind-the-back press, pivoted shoulder press (upper body), and calf lifts, supported squats, outer/inner thigh scissors, and forward and back leg glide (lower body), and finally, a cool-down period (5-10 minutes) comprising stretching exercises.
Other Names:
  • Combined exercise in water
Experimental: Combined physical exercise in water
Combined physical exercise performed in water 3 times per week.
Other: Exercise
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.
Other Names:
  • Physical exercise
  • Combined exercise
Other: Exercise
The activities for the Water Exercise (WE) group will be divided into segments: An aerobic portion (15-20 minutes) involving water walking and jogging combined with arm movements; A resistance portion (35 minutes) including chest/upper back guidance, chest back press, behind-the-back press, pivoted shoulder press (upper body), and calf lifts, supported squats, outer/inner thigh scissors, and forward and back leg glide (lower body), and finally, a cool-down period (5-10 minutes) comprising stretching exercises.
Other Names:
  • Combined exercise in water
Experimental: Control Group
The control group will not performed physical exercise for ten weeks.
Other: Control
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.
Other Names:
  • Control group
  • No intervention group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (Hb1Ac)
Time Frame: 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.
10 weeks
Blood pressure
Time Frame: 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.
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 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
10 weeks
Lipid Profile (LDL, HDL, VLDL and Triglycerides)
Time Frame: 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.
10 weeks
Body Mass Index (BMI)
Time Frame: 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).
10 weeks
Fasting glucose
Time Frame: 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).
10 weeks
Agility
Time Frame: 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.
10 weeks
Cardiorespiratory fitness
Time Frame: 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
10 weeks
Hand grip strength
Time Frame: 10 weeks
The handgrip strength test will be performed with a calibrated device and the test protocol will be guided by official guidelines.
10 weeks
Sit and stand test
Time Frame: 10 weeks
The test will measure the strength of the lower limbs of elderly people and will be guided by official guidelines
10 weeks
Balance test
Time Frame: 10 weeks
Balance will be analyzed through a biomechanical assessment with a force platform for each volunteer.
10 weeks
Muscle electrical activity
Time Frame: 10 weeks
The electrical activity of the vastus medialis and lateralis muscles will be assessed with surface electromyography electrodes.
10 weeks
World Health Organization Quality of Life - WHOQOL questionnaire
Time Frame: 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.
10 weeks
Internation Physical Activity - IPAQ questionnaire
Time Frame: 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.
10 weeks
Pittsburgh Sleep Quality Index - PSQIquestionnaire
Time Frame: 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.
10 weeks
Depression, Anxiety, and Stress Scale - DASS 21
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Foundation for Science and Technology, Portugal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel M Gonçalves, Professor, Universidade do Porto
  • Principal Investigator: Victor Hugo V Carrijo, MsC. Physioterapy, Universidade do Porto
  • Principal Investigator: Mario Jorge O Costa, Professor, Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEFADE 27_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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