Complementary Therapies in the Aging Process of People Living With HIV

NCT06731491 | Not Yet Recruiting

• 1 other identifier: CAAE:78708524.5.0000.5659
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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).

Conditions

HIV

Keywords

HIV; aging; concurrent training; people living with hiv; massage

Outcome Measures

Primary Outcomes (16)

• Dual-energy X-ray absorptiometry

  Quantifying masses: visceral and subcutaneous fat, lean and bone, detecting values for the total body and by segments (upper limbs, trunk, lower limbs and head) using kg and % of total weight as units of measurement.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Biomarkers associated with aging

  The biomarkers will be: IL-1β, IL-2, IL-10, IL-12, IL-17A, IL-18, IFN-γ, cIAP, XIAP, Caspase 3, Caspase 8, Caspase 9, TGFβ-1, BAX protein, TNF-α, IL-6, hsCRP and PBMC: prelamin-A, p16INK4a, p21WAF-1, p53 and activated phospho-p53, sCD14 (unit/ml)

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Quality of sleep

  Sleep quality will be assessed before and after interventions using the validated Pittsburgh Sleep Quality Index (PSQI) questionnaire for Brazil. The PSQI measures sleep quality retrospectively over the previous month using self-report/recall. It consists of nineteen individual items that assess seven components of sleep quality: (1) sleep duration; (2) sleep disturbance; (3) sleep latency; (4) daytime dysfunction due to sleepiness; (5) sleep efficiency; (6) overall sleep quality; and (7) use of sleep medications. These seven-component scores (scored from 0 to 3) are summed to produce a global score between 0 and 21, with higher scores indicating poorer sleep quality. A global PSQI score ≤5 indicates good sleep quality and \>5 indicates poor sleep quality. PSQI has demonstrated good psychometric performance in Brazil.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Handgrip Strength Measurement

  Three attempts will be made on the dominant hand, with one-minute intervals between them, and the highest measurement in kg will be recorded.

  From the start of recruitment to the end of the interventions there will be approximately 15 weeks.

• Mobility Performance

  The test is performed by walking at the highest speed for 6 minutes. The result will be obtained from the number of meters walked during the test.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Frailty syndrome assessment

  Questions will be asked to assess the five components of the Frailty Phenotype, proposed by Fried. Participants with three or more impairments in these components will be classified as frail, and those with one or two, as pre-frail. Those with all negative tests for the components of the frailty phenotype will be considered robust or non-frail.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Knee extension muscle strength in isokinetic

  The knee extension test will be performed with five repetitions, considering the peak torque value of the concentric contraction in the unit newton per meter (Nm) for recording

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Gait assessment

  The gait assessment will be performed using the Timed Up and Go (TUG) test. The evaluator starts the timing when the participant stands up, and stops only when the participant is sitting in the chair with their arms and torso supported. The time recorded is recorded in seconds.

  The time between the start of recruitment and the end of the interventions will be approximately 15 weeks.

• Balance assessment

  The Berg Balance Scale will be used to assess balance. It consists of 14 items related to balance and postural control. The total score is 56 points and, depending on the score, it is possible to determine whether balance is impaired (0-20), acceptable (21-40) or good (41-56).

  The period from the start of recruitment to the end of the interventions will be approximately 15 weeks.

• Self-perception of health

  To assess self-perceived health, two questions from the WHOQOL-HIV-Bref will be used. This is an abbreviated instrument developed by the World Health Organization (2003) to assess the quality of life of people living with HIV and validated in Brazil. It consists of 31 questions to assess six domains (Physical, Psychological, Level of Independence, Social Relationships, Environment and Spirituality) and the overall state of quality of life and health perception. Five responses are possible on a Likert scale with values from one to five. The score ranges from 4 to 20, with higher scores indicating better quality of life.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Self-esteem

  Self-esteem will be assessed using the Rosenberg self-esteem scale, validated in Brazil. The scale has 10 sentences, 6 referring to positive self-image and self-worth, and the other 4 referring to negative self-image or self-deprecation. Three Likert-style scores are possible: "I agree," "I neither agree nor disagree," and "I disagree," and the higher the score on the scale, the higher the level of self-esteem.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Quality of Life and Health Perception

  The WHOQOL-HIV-Bref, an instrument developed by the World Health Organization (2003) to assess the quality of life of people living with HIV, has been validated in Brazil. It consists of 31 questions to assess six domains (Physical, Psychological, Level of Independence, Social Relationships, Environment and Spirituality) and the overall state of quality of life and health perception. Five responses are possible on a Likert scale with values from one to five, the score ranges from 4 to 20, and higher scores indicate better quality of life.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Perception of body image

  Body image perception will be assessed using the Stunkard silhouette assessment scale, adapted and validated for Brazil, in which a series of silhouettes with a given value are presented to participants so that they can indicate the one that most resembles their current body perception and the silhouette they consider ideal. Subsequently, the size and shape currently perceived are compared with the size and shape considered ideal, using the value of the indicated silhouettes, subtracting the value considered ideal from the current value. The result ranges from -8 to 8 and indicates the discrepancy score that reveals the level of dissatisfaction with body image, with zero being the value for satisfaction with body image and values other than zero being dissatisfaction with body image.

  From the start of recruitment to the end of the interventions will be approximately 15 weeks.

• Anxiety and Depression

  The Hospital Anxiety and Depression Scale (HAD) by Zigmond and Snaith, which has been validated in Brazil. The scale consists of 14 questions, seven of which assess anxiety (HADS-A) and seven assess depression (HADS-D). The score for each subscale ranges from 0 to 21 points, and the cutoff score for determining anxiety or depression is greater than or equal to nine points.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Cognitive function

  MOCA- Montreal Cognitive Assessment - Cognitive screening questionnaire that investigates the following factors: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. It is also validated in Brazil. The questionnaire consists of specific sections for each factor, totaling 30 points. In addition, it is possible to add one point if the assessed person's years of schooling are ≤ 12 years.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

• Medication adherence

  The "Cuestionario para la Evaluación de la Adhesión al Tratamiento Antiretroviral" (CEAT-VIH), by Remo, validated in Brazil, will be used to assess adherence to drug therapy. It is a self-administered instrument with 20 questions. The score is given by the sum of all items and ranges from a minimum of 17 to 89 points; the higher the score, the greater the drug adherence.

  From the beginning of recruitment to the end of the interventions will be approximately 15 weeks.

Secondary Outcomes (11)

• Immunological parameters

  From the beginning of recruitment until the end of the interventions will be approximately 15 weeks.

• Body weight

  From the beginning of recruitment until the end of the interventions will be approximately 15 weeks.

• Determination of Maximum Strength (1RM)

  From the beginning of recruitment to the end of the interventions there will be approximately 15 weeks.

• Physical activity level

  From the start of recruitment to the end of the interventions will be approximately 15 weeks.

• Energy intake

  From the beginning of recruitment to the end of the interventions there will be approximately 15 weeks.

Study Arms (7)

Control Group

NO INTERVENTION

There will be no intervention and group participants will be advised to maintain their routine as normal.

G1

EXPERIMENTAL

Intervention Group - Concurrent Training for People Living with HIV who have been on Antiretroviral Therapy for 10 years or more

Other: Concurrent Training

G2

EXPERIMENTAL

Intervention Group - Concurrent Training for People Living with HIV who have been on Antiretroviral Therapy for less than 10 years

Other: Concurrent Training

G3

EXPERIMENTAL

Intervention Group - Concurrent Training for People Living with HIV who have been on Antiretroviral Therapy for less than 10 years and had CD4/CD8 \< 1

Other: Concurrent Training

G4

EXPERIMENTAL

Intervention Group - Massage Therapy for People Living with HIV who have been on Antiretroviral Therapy for 10 years or more

Other: Massage therapy and Aromatherapy

G5

EXPERIMENTAL

Intervention Group - Massage Therapy for People Living with HIV who have been on Antiretroviral Therapy for less than 10 years

Other: Massage therapy and Aromatherapy

G6

EXPERIMENTAL

Intervention Group - Massage Therapy for People Living with HIV who have been on Antiretroviral Therapy for less than 10 years and have CD4/CD8 \< 1

Other: Massage therapy and Aromatherapy

Interventions

Concurrent Training OTHER

Strength and aerobic training in the same training session for a period of 12 weeks, 3 times a week and with an average training time of 60 minutes

Also known as: exercise, training

G1; G2; G3

Massage therapy and Aromatherapy OTHER

Massage Therapy with Aromatherapy twice a week for a period of 12 weeks and an average time of 40 minutes per session.

Also known as: massage

G4; G5; G6

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Hospital das Clínicas, University of Sao Paulo Medical School: collaborator
• Ministry of Education, Brazil: collaborator

MeSH Terms

Interventions

Exercise; Massage; Aromatherapy

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andre P dos Santos, Professor Doutor

  University of Sao Paulo

  STUDY DIRECTOR

• Euripedes B G Gomide, Professor Doutor

  Claretiano - Centro Universitário, Batatais, Brasil

  STUDY CHAIR

• Gianna F Marchiori, Doutora

  Grupo de Pesquisa em Saúde Coletiva da Universidade Federal do Triângulo Mineiro, Uberaba, Brasil

  STUDY CHAIR

• Jéssica F C Cordeiro, Doutora

  Faculdade de Desporto da Universidade do Porto, Porto, Portugal

  STUDY CHAIR

• Igor M Correia, Doutorando

  University of Sao Paulo

  STUDY CHAIR

• Chimenny A L C de Moraes, Mestre

  University of Sao Paulo

  STUDY CHAIR

• Alcivandro de S Oliveira, Mestrando

  University of Sao Paulo

  STUDY CHAIR

• Camile V R de Oliveira, Graduada

  University of Sao Paulo

  STUDY CHAIR

• Joana Brilhadori, Mestranda

  University of Sao Paulo

  STUDY CHAIR

• Leandro C Nunes, Graduado

  University of Sao Paulo

  STUDY CHAIR

• Lisa F Mazzonetto, Mestre

  University of Sao Paulo

  STUDY CHAIR

• Jeferson R C dos Anjos, Mestre

  University of Sao Paulo

  STUDY CHAIR

• Lara S Silva, Graduanda

  Claretiano - Centro Universitário, Batatais, Brasil

  STUDY CHAIR

• Giovana Finco, Graduada

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Andre P dos Santos, Professor Doutor

CONTACT

+55 16992336963; andrepereira.educa@gmail.com

Igor M Correia, Doutorando

CONTACT

+5516992934605; igor.massari.correia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Non-Randomized and Blinded Parallel Cross-Sectional Clinical Study

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 12, 2024
• Study Start: April 30, 2025
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

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