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

Primary Purpose

Frailty, Quality of Life, Physical Inactivity

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
Body composition
Musculoskeletal and visceral Ultrasound
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty focused on measuring HIV, Frailty, Exercise, Physical function, Quality of life

Eligibility Criteria

50 Years - 120 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hospital Universitario Infanta Leonor
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

People living with HIV group 40 participants

People without HIV

Arm Description

40 participants with HIV

20 participants without HIV

Outcomes

Primary Outcome Measures

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
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
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)

Secondary Outcome Measures

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
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
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
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
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
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.
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)

Full Information

First Posted
June 13, 2022
Last Updated
June 23, 2022
Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT05435521
Brief Title
Impact of a Personalized Multicomponent Exercise Program in Real Conditions Among Older Adults With HIV
Acronym
MOVIhNG
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Quality of Life, Physical Inactivity, Body Composition
Keywords
HIV, Frailty, Exercise, Physical function, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentric prospective longitudinal clinical study with intervention with a control group (Non HIV patients) and a group wih HIV
Masking
None (Open Label)
Masking Description
Masking will not be performed due to the necessity of active supervision and follow up of the activity program
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
People living with HIV group 40 participants
Arm Type
Experimental
Arm Description
40 participants with HIV
Arm Title
People without HIV
Arm Type
Active Comparator
Arm Description
20 participants without HIV
Intervention Type
Behavioral
Intervention Name(s)
Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
Intervention Description
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
Other
Intervention Name(s)
Body composition
Intervention Description
Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device
Intervention Type
Other
Intervention Name(s)
Musculoskeletal and visceral Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
Description
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
Time Frame
12 months
Title
Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
Description
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
Time Frame
12 months
Title
Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP)
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparison of PMEP effects between HIV and non HIV participants of the same age
Description
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
Time Frame
12 months
Title
Comparison of PMEP effects between HIV and non HIV participants of the same age
Description
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
Time Frame
12 months
Title
Comparison of PMEP effects between HIV and non HIV participants of the same age
Description
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
Time Frame
12 months
Title
Comparison of PMEP effects between HIV and non HIV participants of the same age
Description
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
Time Frame
12 months
Title
Assesment of body composition evolution after implementation of PMEP using a segmental multi frequency body composition analyser though electrical impedance
Description
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
Time Frame
12 months
Title
Effects of PMEP in muscular and immunological biomarkers and in microbiome
Description
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.
Time Frame
12 months
Title
Evaluation of PMEP adherence
Description
PMEP adherence rate will be assessed in real life conditions with different supervision levels (narrow, medium and no supervision at all)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available via the Clinical Study Data Request site (currently under development)

Learn more about this trial

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

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