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FrailtyMOVIhNGNCT05435521

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

A study testing Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP), Body composition and Musculoskeletal and visceral Ultrasound in people with Frailty and Quality of Life, run by Hospital Universitario Ramon y Cajal at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Frailty, Quality of Life, Physical Inactivity
What is being tested?
Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP), Body composition and Musculoskeletal and visceral Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSpain
Study dates
1 Jan 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP), Body composition, Musculoskeletal and visceral Ultrasound
Keywords
HIV, Frailty, Exercise, Physical function, Quality of life
Medical subject headings
Frailty, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 compositionOther

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

  • Musculoskeletal and visceral UltrasoundOther

    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

Study groups in NCT05435521
Study groupRoleWhat they receive
People living with HIV group 40 participantsExperimental40 participants with HIV
Receives: Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP); Other: Body composition; Other: Musculoskeletal and visceral Ultrasound
People without HIVActive comparator20 participants without HIV
Receives: Behavioral: Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP); Other: Body composition; Other: Musculoskeletal and visceral Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

  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 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)

    Measured: 12 months

Secondary outcomes (7)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435521
Sponsor's protocol ID
PI20/01078
Acronym
MOVIhNG
Status last verified
Jun 2022
First submitted
13 Jun 2022
Last updated
28 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available via the Clinical Study Data Request site (currently under development)

Publications

  • 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.

    PubMed 38694984

Questions about this trial

What is this clinical trial studying?

A study testing Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP), Body composition and Musculoskeletal and visceral Ultrasound in people with Frailty and Quality of Life, run by Hospital Universitario Ramon y Cajal at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435521, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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