HypertensionNCT06879639
Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure
A study testing Exercise in people with Hypertension and Diabetes, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Diabetes, Osteoarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePortugal
- Study dates
- 9 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being a smoker
- Have severe musculoskeletal problems that prevent you from carrying out physical activities
- Unable to carry out the protocol completely
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Municipal Pavilion of Vila Nova de Famalicão
Vila Nova de Famalicão, Braga District, 4760-104
About this study
Official title: 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?
Read more
Participants in the 2 intervention groups will:
Train 3x per week for 10 weeks at intensities that will progress over the weeks.
- Conditions
- Hypertension, Diabetes, Osteoarthritis, Depression Disorders, Multimorbidity, Respiratory Disorders
- Being tested
- Exercise, Control
- Keywords
- Multimorbidity, Diabetes, High blood pressure, Older people, Combined exercise, Aquatic exercise
- Medical subject headings
- Hypertension, Diabetes Mellitus, Osteoarthritis, Respiration Disorders, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Physical exercise, Combined 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.
ControlOther
Also called Control group, No intervention group
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.
ExerciseOther
Also called Combined exercise in water
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined physical exercise in land | Experimental | Combined physical exercise performed in gym 3 times per week Receives: Other: Exercise |
| Combined physical exercise in water | Experimental | Combined physical exercise performed in water 3 times per week. Receives: Other: Exercise |
| Control Group | Experimental | The control group will not performed physical exercise for ten weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (Hb1Ac)
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.
Measured: 10 weeks
Blood pressure
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.
Measured: 10 weeks
Secondary outcomes (14)
Heart rate variability
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
Measured: 10 weeks
Lipid Profile (LDL, HDL, VLDL and Triglycerides)
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.
Measured: 10 weeks
Body Mass Index (BMI)
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).
Measured: 10 weeks
Fasting glucose
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).
Measured: 10 weeks
Agility
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.
Measured: 10 weeks
Cardiorespiratory fitness
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
Measured: 10 weeks
Hand grip strength
The handgrip strength test will be performed with a calibrated device and the test protocol will be guided by official guidelines.
Measured: 10 weeks
Sit and stand test
The test will measure the strength of the lower limbs of elderly people and will be guided by official guidelines
Measured: 10 weeks
World Health Organization Quality of Life - WHOQOL questionnaire
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.
Measured: 10 weeks
Internation Physical Activity - IPAQ questionnaire
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.
Measured: 10 weeks
Pittsburgh Sleep Quality Index - PSQIquestionnaire
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.
Measured: 10 weeks
Depression, Anxiety, and Stress Scale - DASS 21
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.
Measured: 10 weeks
Balance test
Balance will be analyzed through a biomechanical assessment with a force platform for each volunteer.
Measured: 10 weeks
Muscle electrical activity
The electrical activity of the vastus medialis and lateralis muscles will be assessed with surface electromyography electrodes.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start9 Sep 2024
- Primary completion13 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Sponsor
- Investigators
- Daniel M Gonçalves, Professor, Principal investigator, Universidade do PortoVictor Hugo V Carrijo, MsC. Physioterapy, Principal investigator, Universidade do PortoMario Jorge O Costa, Professor, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879639
- Sponsor's protocol ID
- CEFADE 27_2024
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrijo VHV, Moreira-Goncalves D, Costa MJ. Impact of aquatic versus land exercise on glycated hemoglobin and blood pressure in older adults with multimorbidity: A randomized controlled trial protocol. Contemp Clin Trials. 2026 Sep 23:108481. doi: 10.1016/j.cct.2026.108481. Online ahead of print.
PubMed 42778091
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06879639
- Acronym / sponsor ID
- CEFADE 27_2024
- Conditions
- Hypertension, Diabetes, Osteoarthritis, Depression Disorders, Multimorbidity, Respiratory Disorders
- Keywords
- Multimorbidity, Diabetes, High blood pressure, Older people, Combined exercise, Aquatic exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined physical exercise in land | Experimental | Other: ExerciseCombined physical exercise performed in gym 3 times per week |
| Combined physical exercise in water | Experimental | Other: ExerciseCombined physical exercise performed in water 3 times per week. |
| Control Group | Experimental | Other: ControlThe control group will not performed physical exercise for ten weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Being a smoker
- Have severe musculoskeletal problems that prevent you from carrying out physical activities
- Unable to carry out the protocol completely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Physical exercise, Combined exerciseThe 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 | Combined physical exercise in land |
| ControlAlso: Control group, No intervention groupThe 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 | Control Group |
| ExerciseAlso: Combined exercise in waterThe 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 | Combined physical exercise in water |
Primary outcome
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.
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.
14 secondary outcomes
Heart rate variability
Time frame: 10 weeks
Lipid Profile (LDL, HDL, VLDL and Triglycerides)
Time frame: 10 weeks
Body Mass Index (BMI)
Time frame: 10 weeks
Fasting glucose
Time frame: 10 weeks
Agility
Time frame: 10 weeks
Cardiorespiratory fitness
Time frame: 10 weeks
Hand grip strength
Time frame: 10 weeks
Sit and stand test
Time frame: 10 weeks
World Health Organization Quality of Life - WHOQOL questionnaire
Time frame: 10 weeks
Internation Physical Activity - IPAQ questionnaire
Time frame: 10 weeks
Pittsburgh Sleep Quality Index - PSQIquestionnaire
Time frame: 10 weeks
Depression, Anxiety, and Stress Scale - DASS 21
Time frame: 10 weeks
Balance test
Time frame: 10 weeks
Muscle electrical activity
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 42778091Carrijo VHV, Moreira-Goncalves D, Costa MJ. Impact of aquatic versus land exercise on glycated hemoglobin and blood pressure in older adults with multimorbidity: A randomized controlled trial protocol. Contemp Clin Trials. 2026 Sep 23:108481. doi: 10.1016/j.cct.2026.108481. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M Gonçalves, Professor principal investigator
Universidade do Porto
Victor Hugo V Carrijo, MsC. Physioterapy principal investigator
Universidade do Porto
Mario Jorge O Costa, Professor principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hypertension and Diabetes, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (Hb1Ac) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.