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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Frailty; Body Composition; Physical Inactivity
• Intervention / Treatment: Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP); Other: Body composition; Other: Musculoskeletal and visceral Ultrasound

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: People living with HIV group 40 participants; 40 participants with HIV	Behavioral: 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.; Other: Body composition; Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device; 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
ACTIVE_COMPARATOR: People without HIV; 20 participants without HIV	Behavioral: 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.; Other: Body composition; Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of PMEP effects between HIV and non HIV participants of the same age	In order to measure if the impact of PEMP in older adults with HIV is higher than in non HIV participants, 20 individuals of similar age have been included without HIV infection. Impact of PMEP will be measured analyzing frailty which will be assessed using Fried phenotype in each visit	12 months
Comparison of PMEP effects between HIV and non HIV participants of the same age	In order to measure if the impact of PEMP in older adults with HIV is higher than in non HIV participants, 20 individuals of similar age have been included without HIV infection. Impact of PMEP will be measured using the Short Physical Performance Battery" (SPPB or Guralnik test) which will be measured in each evaluation	12 months
Comparison of PMEP effects between HIV and non HIV participants of the same age	In order to measure if the impact of PEMP in older adults with HIV is higher than in non HIV participants, 20 individuals of similar age have been included without HIV infection. Impact of PMEP will be measured analyzing body composition (BMI) in kg/m^2 which will be measured in each evaluation in order to assess changes throughout study period	12 months
Comparison of PMEP effects between HIV and non HIV participants of the same age	In order to measure if the impact of PEMP in older adults with HIV is higher than in non HIV participants, 20 individuals of similar age have been included without HIV infection. Impact of PMEP will be measured with Rectus femoris in cm measurements of both legs and visceral fat measurements in cm will be performed using ultrasound in each evaluation in order to see evolution in these parameters	12 months
Assesment of body composition evolution after implementation of PMEP using a segmental multi frequency body composition analyser though electrical impedance	Electrical bioimpedance measurement wil be performed in baseline evaluation and 3, 6 and 12 months after initiation of PMEP. The device used is Tanita MC-780 S MA analyzing BMI in kg/m^2	12 months
Effects of PMEP in muscular and immunological biomarkers and in microbiome	At each evaluation (baseline, 3, 6 and 12 months), samples of blood, stool, urine, and saliva will be taken. Immunosenescence and chronic inflammation in HIV are considered at the present moment one of the main drivers of non AIDS comorbidities. Several studies have shown solid conclusions positioning physical activity as a clear intervention which reduces chronic inflammation in individuals without HIV as well as in people living with HIV.	12 months
Evaluation of PMEP adherence	PMEP adherence rate will be assessed in real life conditions with different supervision levels (narrow, medium and no supervision at all)	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; HIV; Quality of life; Frailty; Physical function
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PI20/01078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available via the Clinical Study Data Request site (currently under development)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No