Impact of a Personalized Multicomponent Exercise Program in Real Conditions Among Older Adults With HIV (MOVIhNG)

Madrid Health Service

Status: Active, not recruiting

Conditions: Physical Inactivity; Quality of Life; Frailty; Body Composition

Treatments: Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP); Other: Musculoskeletal and visceral Ultrasound; Other: Body composition

Study type: Interventional

Funder types: Other

Identifiers

NCT05435521

PI20/01078

Details and patient eligibility

About

Longitudinal prospective multicenter study with intervention and control groups and a two-year follow up. Participants will include 40 sedentary adults 50 years old or older with HIV infection and 20 sedentary adults 50 years old or older without HIV infection. Our main objective is to analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on physical function, frailty, and quality of life among older adults with HIV. As secondary objectives, we are going to analyze the effects of a PMEP on body composition, muscle function biomarkers, immunological biomarkers, microbiome, and adherence to PMEP in real conditions under intense, moderate nonexistent monitoring.

Full description

PMEPs will be designed according to the specific characteristics of each participant and their grade of usual physical activity. Physical activity will be registered on physical activity bracelets to get objective information in order to evaluate adherence to the PMEP. A global evaluation of the patients will be made at baseline and months 3, 6, and 12. At each evaluation, samples of blood, stool, urine, and saliva will be taken, and a phone meeting will be scheduled at month 24.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• People living with HIV (Control group not included)
• Age equal or older to 50 years old at initiation of study
• Sedentary individuals: < 150 minutes per week of moderate physical activity.
• Absence of physical limitations which impede the performance of a light or moderate physical activity program

Exclusion criteria

* Individuals with one or more of the following diseases:

• Acute myocardial infarction (in the previous 3-6 months) or unstable angina
• Uncontrolled cardiac arrythmias
• Severe aortic stenosis
• Acute Pericarditis/ Endocarditis
• Poorly controlled high blood pressure (> 180/100 mmHg)
• Acute thromboembolic disease
• Acute severe cardiac heart failure

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

People living with HIV group 40 participants

Experimental group

Description:

40 participants with HIV

Treatment:

Other: Body composition

Other: Musculoskeletal and visceral Ultrasound

Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)

People without HIV

Active Comparator group

Description:

20 participants without HIV

Treatment:

Other: Body composition

Other: Musculoskeletal and visceral Ultrasound

Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)