Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure

NCT06879639 | Completed DMC

• 1 other identifier: CEFADE 27_2024
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 weeks

Secondary Outcomes (14)

• Heart rate variability

  10 weeks

• Lipid Profile (LDL, HDL, VLDL and Triglycerides)

  10 weeks

• Body Mass Index (BMI)

  10 weeks

• Fasting glucose

  10 weeks

• Agility

  10 weeks

Study Arms (3)

Combined physical exercise in land

EXPERIMENTAL

Combined physical exercise performed in gym 3 times per week

Other: Exercise

Combined physical exercise in water

EXPERIMENTAL

Combined physical exercise performed in water 3 times per week.

Other: Exercise

Control Group

EXPERIMENTAL

The control group will not performed physical exercise for ten weeks.

Other: Control

Interventions

Exercise OTHER

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.

Also known as: Physical exercise, Combined exercise

Combined physical exercise in land

Control OTHER

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.

Also known as: Control group, No intervention group

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being a smoker
• Have severe musculoskeletal problems that prevent you from carrying out physical activities
• Unable to carry out the protocol completely

Sponsors & Collaborators

• Universidade do Porto: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

Municipal Pavilion of Vila Nova de Famalicão

Vila Nova de Famalicão, Braga District, 4760-104, Portugal

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Osteoarthritis; Respiration Disorders; Dyslipidemias

Interventions

Exercise; Control Groups; Water

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Respiratory Tract Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 17, 2025
• Study Start: September 9, 2024
• Primary Completion: December 13, 2024
• Study Completion: January 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)