Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure

NCT ID: NCT06879639

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined physical exercise in land

Combined physical exercise performed in gym 3 times per week

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Combined physical exercise in water

Combined physical exercise performed in water 3 times per week.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Control Group

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

Group Type: EXPERIMENTAL

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Physical exercise; Combined exercise; Control group; No intervention group; Combined exercise in water

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel M Gonçalves, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Victor Hugo V Carrijo, MsC. Physioterapy

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Mario Jorge O Costa, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

Municipal Pavilion of Vila Nova de Famalicão

Vila Nova de Famalicão, Braga District, Portugal

Countries

Portugal

Other Identifiers

CEFADE 27_2024

Identifier Type: -

Identifier Source: org_study_id