Clinical trial NCT06879639: Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Osteoarthritis
Depression Disorders
Multimorbidity
Respiratory Disorders
Sarcopenia in Elderly
Dyslipidemia
High Blood Cholesterol
Obese Patients
Keywords: Multimorbidity
Diabetes
High blood pressure
Older people
Combined exercise
Aquatic exercise
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2025-03-17
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glycated hemoglobin (Hb1Ac)
timeFrame: 10 weeks
measure: Blood pressure
timeFrame: 10 weeks
Secondary outcomes:
measure: Heart rate variability
timeFrame: 10 weeks
measure: Lipid Profile (LDL, HDL, VLDL and Triglycerides)
timeFrame: 10 weeks
measure: Body Mass Index (BMI)
timeFrame: 10 weeks
measure: Fasting glucose
timeFrame: 10 weeks
measure: Agility
timeFrame: 10 weeks
measure: Cardiorespiratory fitness
timeFrame: 10 weeks
measure: Hand grip strength
timeFrame: 10 weeks
measure: Sit and stand test
timeFrame: 10 weeks
measure: World Health Organization Quality of Life - WHOQOL questionnaire
timeFrame: 10 weeks
measure: Internation Physical Activity - IPAQ questionnaire
timeFrame: 10 weeks
measure: Pittsburgh Sleep Quality Index - PSQIquestionnaire
timeFrame: 10 weeks
measure: Depression, Anxiety, and Stress Scale - DASS 21
timeFrame: 10 weeks
measure: Balance test
timeFrame: 10 weeks
measure: Muscle electrical activity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Vila Nova De Famalicão
country: Portugal
facility: Municipal Pavilion of Vila Nova de Famalicão
state: Braga
Study officials:
affiliation: Universidade do Porto
name: Daniel M Gonçalves, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Porto
name: Victor Hugo V Carrijo, MsC. Physioterapy
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Porto
name: Mario Jorge O Costa, Professor
role: PRINCIPAL_INVESTIGATOR
References: