Clinical trial NCT05435521: Impact of a Personalized Multicomponent Exercise Program in Real Conditions Among Older Adults With HIV
Official title: MOVIhNG Study: Impact of a Personalized Multicomponent Exercise Program in Real Conditions on Physical Function, Frailty, and Quality of Life Among Older Adults With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Quality of Life
Physical Inactivity
Body Composition
Keywords: HIV
Frailty
Exercise
Physical function
Quality of life
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2022-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric prospective longitudinal clinical study with intervention with a control group (Non HIV patients) and a group wih HIV
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
timeFrame: 12 months
measure: Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
timeFrame: 12 months
measure: Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of PMEP effects between HIV and non HIV participants of the same age
timeFrame: 12 months
measure: Comparison of PMEP effects between HIV and non HIV participants of the same age
timeFrame: 12 months
measure: Comparison of PMEP effects between HIV and non HIV participants of the same age
timeFrame: 12 months
measure: Comparison of PMEP effects between HIV and non HIV participants of the same age
timeFrame: 12 months
measure: Assesment of body composition evolution after implementation of PMEP using a segmental multi frequency body composition analyser though electrical impedance
timeFrame: 12 months
measure: Effects of PMEP in muscular and immunological biomarkers and in microbiome
timeFrame: 12 months
measure: Evaluation of PMEP adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: