Skip to content

Comparing two types of physical training and conditioning in patients with HIV/AIDS

Efficacy and safety of a functional multimodal interval physical training protocol vs conventional training on physical function in hospitalized sarcopenic patients with HIV/AIDS: a randomized clinical trial - HIV; AIDS Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7hsd9qj
Enrollment
32
Registered
2025-12-02
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia HIV disease resulting in other infectious and parasitic diseases

Interventions

This is a randomized clinical trial that will include hospitalized patients with HIV/AIDS and sarcopenia at the INI/FIOCRUZ hospital center (CH/INI). The patients will be randomized and allocated into

Sponsors

Instituto Nacional de Infectologia Evandro Chagas INI/FIOCRUZ
Lead Sponsor
Instituto Nacional de Infectologia Evandro Chagas INI/FIOCRUZ
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age over 18 years; handgrip test with values greater than 27 KgF for men and less than 16 KgF for women and/or; five-repetition sit-to-stand test (STS5) longer than 15 seconds or inability to perform the test; walking speed less than or equal to 0.8 m/s; and two-minute stationary walk test (TM2) showing signs of low exercise tolerance; low exercise tolerance will be defined as subjective perception of effort by BORG scale greater than or equal to 3 and/or signs of respiratory discomfort (nasal flaring, intercostal retraction) and/or drop in peripheral oxygen saturation (SpO2) less than or equal to 90% during the test, according to the guidelines of the American College of Sports Medicine.

Exclusion criteria

Exclusion criteria: Patients over 60 years old; use of supplemental oxygen less than 5 L/min; refusal to undergo assessment tests; hemodynamic and ventilatory instability; states of catabolism: SIRS, sepsis, symptomatic anemia, among others; osteomyoarticular and/or neurological injury; general condition of physical or mental deterioration that prevents patient cooperation; muscle strength grade less than or equal to 2 in any limb evaluated by the Medical Research Council scale

Design outcomes

Primary

MeasureTime frame
The cardiorespiratory fitness is expected to be assessed through the two-minute step test;It is expected to evaluate and quantify skeletal muscle fitness through handgrip strength and the five-repetition sit-to-stand test, while the four-meter walking speed test will be used to measure functional capacity;The safety of multimodal functional and conventional interval physical training is expected to be evaluated by identifying adverse events and patient tolerability during the application of the protocol, as well as through the collected and analyzed variables: blood pressure, respiratory rate, heart rate, and peripheral oxygen saturation

Secondary

MeasureTime frame
It is expected to comparatively evaluate between the groups the length of hospital stay and quality of life using the World Health Organization Quality of Life – HIV bref (WHOQOL-HIV bref) questionnaire at admission and three months after hospital discharge;It is expected to comparatively evaluate among the groups the physiological variables blood pressure, peripheral oxygen saturation, respiratory rate, and heart rate, which will be collected before, during, and after training. Covariates from laboratory tests, such as inflammatory markers like C-reactive protein (CRP), glycated hemoglobin (HbA1c), glucose, and lipid profile: Total Cholesterol, Triglycerides,Low-density lipoprotein (LDL), High-intensity lipoprotein (HDL), will be collected at admission. In addition to the physiological variables, adverse events such as falls from the bed or from height, and displacement or avulsion of devices will be monitored for safety assessment;Patients are expected to be assessed for Body Mass Index (BMI) before and after training. The presence of sarcopenia will be evaluated according to the 2018 European Sarcopenia Consensus. To estimate muscle mass, calf circumference will be used according to the Sarcopenia Geriatric Scale (SARCO-GS)

Countries

BR

Contacts

Public ContactMônica Cruz

Instituto Nacional de Infectologia Evandro Chagas INI/FIOCRUZ

monica.cruz@ini.fiocruz.br+55-21-970007253

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Sep 19, 2026