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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Frailty Quality of Life Physical Inactivity Body Composition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Multicentric prospective longitudinal clinical study with intervention with a control group (Non HIV patients) and a group wih HIV

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Masking will not be performed due to the necessity of active supervision and follow up of the activity program

Study Groups

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People living with HIV group 40 participants

40 participants with HIV

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Physical activity expert will design for each participant a personalized exercise program according to baseline situation and previous physical activity. Both will be measured prior to initiation of activity program. Each participant is free to perform physical activity program at his house, outdoor or in a gym as long as it fulfills the prespecified requirements. Exercise programs will be acquired a more personalized shape during the course of the study.

In order to motivate participants, personal motivational messages will be sent each week through mail contact or using "WhatsApp" Social Media.

Physical activity will be registered in an activity wristband delivered to each participant at baseline evaluation.

Body composition

Intervention Type OTHER

Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device

Musculoskeletal and visceral Ultrasound

Intervention Type OTHER

Quadriceps muscle ultrasound (US) of the rectus femoris measured in each evaluation in order to analyze the effects of PMEP Visceral fat will be analyzed in each visit

People without HIV

20 participants without HIV

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Physical activity expert will design for each participant a personalized exercise program according to baseline situation and previous physical activity. Both will be measured prior to initiation of activity program. Each participant is free to perform physical activity program at his house, outdoor or in a gym as long as it fulfills the prespecified requirements. Exercise programs will be acquired a more personalized shape during the course of the study.

In order to motivate participants, personal motivational messages will be sent each week through mail contact or using "WhatsApp" Social Media.

Physical activity will be registered in an activity wristband delivered to each participant at baseline evaluation.

Body composition

Intervention Type OTHER

Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device

Musculoskeletal and visceral Ultrasound

Intervention Type OTHER

Quadriceps muscle ultrasound (US) of the rectus femoris measured in each evaluation in order to analyze the effects of PMEP Visceral fat will be analyzed in each visit

Interventions

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

Physical activity expert will design for each participant a personalized exercise program according to baseline situation and previous physical activity. Both will be measured prior to initiation of activity program. Each participant is free to perform physical activity program at his house, outdoor or in a gym as long as it fulfills the prespecified requirements. Exercise programs will be acquired a more personalized shape during the course of the study.

In order to motivate participants, personal motivational messages will be sent each week through mail contact or using "WhatsApp" Social Media.

Physical activity will be registered in an activity wristband delivered to each participant at baseline evaluation.

Intervention Type BEHAVIORAL

Body composition

Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device

Intervention Type OTHER

Musculoskeletal and visceral Ultrasound

Quadriceps muscle ultrasound (US) of the rectus femoris measured in each evaluation in order to analyze the effects of PMEP Visceral fat will be analyzed in each visit

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes