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

NCT05435521 | Unknown

• 1 other identifier: PI20/01078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty; Quality of Life; Physical Inactivity; Body Composition

Keywords

HIV; Frailty; Exercise; Physical function; Quality of life

Outcome Measures

Primary Outcomes (3)

• Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)

  To analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on physical function among older adults with HIV. Physical function will be assessed using Short Physical Performance Battery" (SPPB or Guralnik test) will be measured in each evaluation

  12 months

• Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)

  To analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on frailty among older adults with HIV. Frailty will be assessed using Fried phenotype in each visit

  12 months

• Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)

  To analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on quality of life among older adults with HIV. Quality of life will be assessed using World Health Organization Quality of Life HIV instrument (WHOQOL-HIV-BREF)

  12 months

Secondary Outcomes (7)

• Comparison of PMEP effects between HIV and non HIV participants of the same age

  12 months

• Comparison of PMEP effects between HIV and non HIV participants of the same age

  12 months

• Comparison of PMEP effects between HIV and non HIV participants of the same age

  12 months

• Comparison of PMEP effects between HIV and non HIV participants of the same age

  12 months

• Assesment of body composition evolution after implementation of PMEP using a segmental multi frequency body composition analyser though electrical impedance

  12 months

Study Arms (2)

People living with HIV group 40 participants

EXPERIMENTAL

40 participants with HIV

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

People without HIV

ACTIVE COMPARATOR

20 participants without HIV

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

Interventions

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

People living with HIV group 40 participants; People without HIV

Body composition OTHER

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

People living with HIV group 40 participants; People without HIV

Musculoskeletal and visceral Ultrasound 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 living with HIV group 40 participants; People without HIV

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• Branas F, Diaz-Alvarez J, Fernandez-Luna J, Vasquez-Brolen BD, Garcia-Molina R, Moreno E, Ryan P, Martinez-Sanz J, Luna L, Martinez M, Dronda F, Sanchez-Conde M. A 12-week multicomponent exercise program enhances frailty by increasing robustness, improves physical performance, and preserves muscle mass in older adults with HIV: MOVIhNG study. Front Public Health. 2024 Apr 17;12:1373910. doi: 10.3389/fpubh.2024.1373910. eCollection 2024.

  PMID: 38694984 DERIVED

MeSH Terms

Conditions

Frailty; Sedentary Behavior; Motor Activity

Interventions

Pliability; Body Composition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be performed due to the necessity of active supervision and follow up of the activity program
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 28, 2022
• Study Start: January 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (2)