Clinical trial NCT06731491: Complementary Therapies in the Aging Process of People Living With HIV
Official title: Terapias Complementares no Processo de Envelhecimento de Pessoas Vivendo Com HIV: Uma Abordagem Multi-design Sobre o Efeito da Massoterapia, Aromaterapia e do exercício físico
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
aging
concurrent training
people living with hiv
massage
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Hospital das Clínicas, University of Sao Paulo Medical School
name: CAPES Foundation - Ministry of Education, Brazil.
First posted: 2024-12-12
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-Randomized and Blinded Parallel Cross-Sectional Clinical Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: PROBLEM DELIMITATION AND JUSTIFICATION Complementary therapies, including physical exercise and massage therapy, are ways to mitigate the side effects of aging, HIV infection and ART. In parallel, there are studies that seek to propose a way to analyze muscle strength and endurance, balance, walking ability, body composition, immunological, metabolic and biochemical parameters, sarcopenia, frailty syndrome, sleep quality, self-perception of health, self-esteem, perception of body image, anxiety, depression, cognitive function, medication adherence, quality of life, diet and level of physical activity in people living with HIV (PLWH). However, the impact of concurrent training, massage therapy and aromatherapy on these parameters together in PLWH with different times of diagnosis and consequences of the low CD4/CD8 ratio during their clinical history has not yet been investigated.

RELEVANCE Understanding the impact of concurrent training, massage therapy and aromatherapy, as complementary therapies, on physical, biochemical and psychosocial parameters according to the time of diagnosis and consequences of the low CD4/CD8 ratio is a way to evaluate the effect of these interventions on different profiles of the same population, and consequently, favor the development of other studies that can propose training and massage for PLWH, considering the time of diagnosis and the impact of HIV on their body.

GENERAL OBJECTIVE To evaluate the impact of complementary therapies on variables associated with the aging of people living with HIV, considering the time of diagnosis and the CD4/CD8 ratio.

Study design The research project has a multidesign characteristic, that is, different study designs will be used that communicate with each other to provide a broad approach to the effect of complementary therapies on the aging process of PLWH. The study designs used will be: systematic review and meta-analysis, cross-sectional observational study, and blinded clinical trial.

Intervention protocol The kinetics of heart rate and oxygen consumption, peak running speed (Vpeak), running speed at the ventilatory threshold, and respiratory exchange ratio will be assessed before and after the 12-week intervention. In addition, the estimated maximum load (1RM) in strength training will be verified in exercises for the upper limbs: front pulldown, bench press on the machine, and lateral elevation of the shoulders with dumbbells; and lower limbs: leg press 90°, adductor and abductor chair, and plantar flexion on the bench before and after the 12-week intervention. Massage and aromatherapy sessions will be performed once a week for 12 weeks for 30 minutes in the dorsal region. The massage protocol that will be used includes classic massage movements (superficial sliding, deep sliding, friction, rolling, kneading) with grape seed vegetable oil mixed with lavender essential oils, being a 2% mixture (50 drops of essential oil for 100ml of vegetable oil).

Statistical analysis In this project, the variables considered as independent are concurrent training and relaxing massage with the use of essential oils. An initial exploratory analysis will be performed to check the distribution behavior of the data. If the data present a normal distribution, a descriptive analysis (measures of central tendency, SD, CI) of the outcome variables in the periods (pre- and post-intervention) will be performed. If there is no normal distribution of the data, the description of the outcome variables will occur through median, minimum and maximum value, and 25th and 75th interquartile range.

If there is a normal distribution of the data, the t-test for dependent samples will be used to identify differences in the pre- and post-intervention period for the intervention and control groups. Subsequently, the one-way ANOVA will be used to verify differences between the intervention and control groups, in the pre- and post-intervention period. If there is no normal distribution, the Mann-Whitney U test for dependent samples will be used to identify differences in the pre- and post-intervention period for the intervention and control groups. Subsequently, the Wilcoxon test for independent samples will be used to verify differences between the intervention and control groups, in the pre- and post-intervention period. It is not the objective of this project to compare the effect of the intervention between concurrent training and relaxing massage with the use of essential oils. The effect size (η2) of concurrent training and relaxing massage with the use of essential oils on the outcome variables will be calculated. The analyses will be performed in SPSS 23.0 software, assuming prior statistical significance (α = 0.05).

Detailed description: PROBLEM DELIMITATION AND JUSTIFICATION Complementary therapies, including physical exercise and massage therapy, are ways to mitigate the side effects of aging, HIV infection and ART. In parallel, there are studies that seek to propose a way to analyze muscle strength and endurance, balance, walking ability, body composition, immunological, metabolic and biochemical parameters, sarcopenia, frailty syndrome, sleep quality, self-perception of health, self-esteem, perception of body image, anxiety, depression, cognitive function, medication adherence, quality of life, diet and level of physical activity in people living with HIV (PLWH). However, the impact of concurrent training, massage therapy and aromatherapy on these parameters together in PLWH with different times of diagnosis and consequences of the low CD4/CD8 ratio during their clinical history has not yet been investigated.

RELEVANCE Understanding the impact of concurrent training, massage therapy and aromatherapy, as complementary therapies, on physical, biochemical and psychosocial parameters according to the time of diagnosis and consequences of the low CD4/CD8 ratio is a way to evaluate the effect of these interventions on different profiles of the same population, and consequently, favor the development of other studies that can propose training and massage for PLWH, considering the time of diagnosis and the impact of HIV on their body.

GENERAL OBJECTIVE To evaluate the impact of complementary therapies on variables associated with the aging of people living with HIV, considering the time of diagnosis and the CD4/CD8 ratio.

Specific objectives

In adults living with HIV:

1. Conduct a systematic review of the literature with the purpose of compiling scientific evidence addressing the effects of concurrent training on a variety of variables, including sleep quality, self-perception of health, self-esteem, quality of life, perception of body image, anxiety, depression, cognitive function, medication adherence, anthropometric measurements, immunological and metabolic parameters, biomarkers associated with aging, body composition, motor function and frailty.
2. Conduct a systematic review of the literature to compile scientific evidence related to the effects of massage therapy with the use of essential oils on the following variables: sleep quality, self-perception of health, self-esteem, quality of life, perception of body image, anxiety, depression, cognitive function, medication adherence, as well as immunological and metabolic parameters.
3. Investigate the occurrence of frailty syndrome in adults living with HIV, considering temporal variables related to HIV diagnosis and the implications of the low CD4/CD8 ratio.
4. To evaluate the impact of concurrent training through pre- and post-intervention determination and comparative analyses on a wide range of variables, including sleep quality, self-perception of health, self-esteem, quality of life, perception of body image, anxiety, depression, cognitive function, medication adherence, anthropometric measurements, immunological and metabolic parameters, biomarkers associated with aging, body composition, motor function and frailty. This examination will be carried out according to the times of HIV diagnosis and the consequences associated with the low CD4/CD8 ratio.
5. To evaluate the effect of massage therapy with the use of essential oils in adults living with HIV, analyzing variables such as sleep quality, self-perception of health, self-esteem, quality of life, perception of body image, anxiety, depression, cognitive function, medication adherence, as well as immunological and metabolic parameters. This evaluation will be carried out considering the times of HIV diagnosis and the implications of the low CD4/CD8 ratio.

Study design The research project has a multidesign characteristic, that is, different study designs will be used that communicate with each other to provide a broad approach to the effect of complementary therapies on the aging process of PLWH. The study designs used will be: systematic review and meta-analysis, cross-sectional observational study, and blinded clinical trial.

Intervention protocol The kinetics of heart rate and oxygen consumption, peak running speed (Vpeak), running speed at the ventilatory threshold, and respiratory exchange ratio will be assessed before and after the 12-week intervention. In addition, the estimated maximum load (1RM) in strength training will be verified in exercises for the upper limbs: front pulldown, bench press on the machine, and lateral elevation of the shoulders with dumbbells; and lower limbs: leg press 90°, adductor and abductor chair, and plantar flexion on the bench before and after the 12-week intervention. Massage and aromatherapy sessions will be performed once a week for 12 weeks for 30 minutes in the dorsal region. The massage protocol that will be used includes classic massage movements (superficial sliding, deep sliding, friction, rolling, kneading) with grape seed vegetable oil mixed with lavender essential oils, being a 2% mixture (50 drops of essential oil for 100ml of vegetable oil).

Concurrent training The concurrent training will consist of a warm-up phase (a 5-minute light-to-moderate walk), followed by 40 minutes of strength training using free weights and machines to work the body's main muscle groups, and 20 minutes of aerobic training, controlling heart rate reserve (HR) on a treadmill. Finally, there will be a 5-minute cool-down phase (active stretching). The training program will be performed 3 times a week for 12 weeks, totaling 36 training sessions. The periodization was based on the guidelines of the American College of Sports Medicine.

For strength training, the movement cadence will be 1 second and 2 seconds for the concentric and eccentric phases, respectively. The time interval between each exercise will be between 90-120 seconds.

The intervention will be performed at LaCiDH of EEFERP/USP. The aerobic training load will be adjusted using HRres, calculated using the following equation:

HRres = \[(HRmax - HRrest) x intensity\] + HRrest

The resting heart rate will be assessed before the prescription of aerobic exercise and at the end of the fourth and eighth weeks for load adjustment. Participants will remain at rest in a chair for 10 minutes to record their HR, and then their HR will be taken to calculate their resting HR. The maximum heart rate (HRmax) will be calculated using the equation proposed by Tanaka et al.

The initial load for strength training will be determined during the first week of the intervention protocol. The load will be adjusted until it corresponds to 10-12 maximum repetitions for each exercise. Load adjustments will occur weekly and will be performed as follows: during the last weekly training session, participants will be instructed to perform 10 (first 8 weeks) or 8 repetitions (9th week onwards) in the first set for each exercise, and as many repetitions as possible before concentric failure in the last set of each exercise. For each repetition greater than 10 (first 8 weeks) or 8 (9th week onwards), 1 kg will be added for lower limb exercises and 0.5 kg for upper limb exercises. This increase will be incorporated into the following training session the following week.

Monitoring of concurrent training Before each training session, measurements of blood pressure, HR and blood oxygen saturation (SpO2) will be taken, following the standards of the SBC, SBH and SBN (57) and SBPT (58). The measurements will be taken using a stethoscope and aneroid sphygmomanometer of the "Premium®" brand, a heart rate monitor of the "Polar FT7®" brand and a digital oximeter of the "Oximeter®" brand. In the absence of contraindicated vital signs, the training protocol will be carried out. Additionally, the HR and BP of the participants will be monitored throughout the training period.

Relaxing massage using essential oils 12 sessions of relaxing massage and aromatherapy will be carried out, lasting 30 minutes, on the back of the trunk. The intensity of the pressure of the relaxing massage will be moderate, which corresponds to the pressure exerted on the vulva of the sphygmomanometer between 50 and 80 mmHg. The massage will be performed by two professionals with experience in performing the massage and applying the pressure necessary to stimulate the relaxing massage. A mixture of grape seed oil and lavender essential oil will be used.

Data collection Data will be collected by collecting information from the research participant, including anamnesis and questionnaires that assess sleep quality, self-perception of health, self-esteem, quality of life, perception of body image, anxiety, depression, cognitive function and adherence to medication therapy. In addition, some anthropometric measurements will be taken. This information will be collected by the research team. Routine laboratory tests - to assess immunological and metabolic parameters, and biochemical variables associated with aging - will be performed by laboratory technicians from HC-FMRP/USP. The analysis of multicompartmental body composition by Dual Energy X-ray Absorptiometry (DXA) to estimate fat mass, lean mass, and bone mineral density will be performed by prior appointment by a radiology technician responsible for operating the equipment at LaCiDH of EEFERP/USP. Motor tests to estimate maximum load in concurrent training exercises, handgrip strength, isokinetic knee extension muscle strength, and gait will be evaluated at LaCiDH of EEFERP/USP. Balance will be evaluated at the Laboratory of Biomechanics and Motor Control of EEFERP/USP. Aerobic variables will be verified at the Laboratory of Exercise Physiology and Metabolism (LAFEM) of EEFERP/USP.

Statistical analysis In this project, the variables considered as independent are concurrent training and relaxing massage with the use of essential oils. An initial exploratory analysis will be performed to check the distribution behavior of the data. If the data present a normal distribution, a descriptive analysis (measures of central tendency, SD, CI) of the outcome variables in the periods (pre- and post-intervention) will be performed. If there is no normal distribution of the data, the description of the outcome variables will occur through median, minimum and maximum value, and 25th and 75th interquartile range.

If there is a normal distribution of the data, the t-test for dependent samples will be used to identify differences in the pre- and post-intervention period for the intervention and control groups. Subsequently, the one-way ANOVA will be used to verify differences between the intervention and control groups, in the pre- and post-intervention period. If there is no normal distribution, the Mann-Whitney U test for dependent samples will be used to identify differences in the pre- and post-intervention period for the intervention and control groups. Subsequently, the Wilcoxon test for independent samples will be used to verify differences between the intervention and control groups, in the pre- and post-intervention period. It is not the objective of this project to compare the effect of the intervention between concurrent training and relaxing massage with the use of essential oils. The effect size (η2) of concurrent training and relaxing massage with the use of essential oils on the outcome variables will be calculated. The analyses will be performed in SPSS 23.0 software, assuming prior statistical significance (α = 0.05).

Eligibility criteria: Inclusion Criteria:

* Both sexes
* Age ≥ 50 years
* Diagnosed with HIV at age ≥ 18 years
* HIV diagnosis for \> 6 months
* Use of ART with unchanged medication for \> 6 months
* Clinically stable, with undetectable viral load (\< 40 copies per ml of blood)
* Not undergoing treatment for opportunistic diseases or cancer
* Maintaining stable body weight (less than 10% variation in the past six months)
* No musculoskeletal disorders impairing the ability to perform exercise (e.g., - --- Duchenne Muscular Dystrophy and Becker Muscular Dystrophy)
* Medical clearance for physical exercise
* Not using medications that could significantly alter body composition (e.g., testosterone, growth hormone, and insulin-like growth factor 1)
* Not pregnant
* Not breastfeeding
* Not using prosthetics
* No amputations of any body part
* Not engaged in a regular physical exercise program in the past six months

Exclusion Criteria:

* Showing any symptoms that would contraindicate their continued participation in the training program, or that would result in risks due to the practice of exercises
* Showing concurrent diseases, classified as (1) infections (Mycobacterium Avium, Cytomegalovirus, Pneumocystis Carinii Pneumonia, Herpes Simplex Virus, Tuberculosis, Toxoplasmosis); (2) neoplasms (Kaposi's Sarcoma, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma), (3) autoimmune diseases (Autoimmune Hemolytic Anemia)
* Declining participation in the study
* Failing to complete all stages of the study, including the minimum of 80% attendance at training sessions

Primary outcomes:
measure: Dual-energy X-ray absorptiometry
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Biomarkers associated with aging
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Quality of sleep
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Handgrip Strength Measurement
timeFrame: From the start of recruitment to the end of the interventions there will be approximately 15 weeks.
measure: Mobility Performance
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Frailty syndrome assessment
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Knee extension muscle strength in isokinetic
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Gait assessment
timeFrame: The time between the start of recruitment and the end of the interventions will be approximately 15 weeks.
measure: Balance assessment
timeFrame: The period from the start of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Self-perception of health
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Self-esteem
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Quality of Life and Health Perception
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Perception of body image
timeFrame: From the start of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Anxiety and Depression
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Cognitive function
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Medication adherence
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
Secondary outcomes:
measure: Immunological parameters
timeFrame: From the beginning of recruitment until the end of the interventions will be approximately 15 weeks.
measure: Body weight
timeFrame: From the beginning of recruitment until the end of the interventions will be approximately 15 weeks.
measure: Determination of Maximum Strength (1RM)
timeFrame: From the beginning of recruitment to the end of the interventions there will be approximately 15 weeks.
measure: Physical activity level
timeFrame: From the start of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Energy intake
timeFrame: From the beginning of recruitment to the end of the interventions there will be approximately 15 weeks.
measure: Peak Oxygen Consumption (VO2peak)
timeFrame: From the start of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Anamnesis
timeFrame: It will only be performed before the intervention.
measure: Metabolic Parameters
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Height
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Skinfold thicknesses
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
measure: Body perimeters
timeFrame: From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Andre P dos Santos, Professor Doutor
role: STUDY_DIRECTOR
affiliation: Claretiano - Centro Universitário, Batatais, Brasil
name: Euripedes B G Gomide, Professor Doutor
role: STUDY_CHAIR
affiliation: Grupo de Pesquisa em Saúde Coletiva da Universidade Federal do Triângulo Mineiro, Uberaba, Brasil
name: Gianna F Marchiori, Doutora
role: STUDY_CHAIR
affiliation: Faculdade de Desporto da Universidade do Porto, Porto, Portugal
name: Jéssica F C Cordeiro, Doutora
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Igor M Correia, Doutorando
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Chimenny A L C de Moraes, Mestre
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Alcivandro de S Oliveira, Mestrando
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Camile V R de Oliveira, Graduada
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Joana Brilhadori, Mestranda
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Leandro C Nunes, Graduado
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Lisa F Mazzonetto, Mestre
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Jeferson R C dos Anjos, Mestre
role: STUDY_CHAIR
affiliation: Claretiano - Centro Universitário, Batatais, Brasil
name: Lara S Silva, Graduanda
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Giovana Finco, Graduada
role: STUDY_CHAIR
References: