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The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).
HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endurance and Resistance Training Exercise | Experimental |
| |
| Control group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance ad Resistance Training Exercise | Behavioral | Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of eligible participants who enrolled in the program out of the number were recruited | At study completion (after 6 weeks) |
| Retention rate | Percentage of patients lost to follow-up | At study completion (after 6 weeks) |
| Adverse events | Percentage of patients who experienced one or more adverse events | At study completion (after 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight (kg) is measured by using a bioelectrical impedance analysis | Assessments at baseline and at 6 weeks |
| Lean body mass | Lean body mass (kg) is measured by using a bioelectrical impedance analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Assessments at baseline and at 6 weeks |
| Fat body mass | Lean body mass (kg) is measured by using a bioelectrical impedance analysis | Assessments at baseline and at 6 weeks |
| C-reactive protein | C-reactive protein is measured by a blood test | Assessments at baseline and at 12 weeks |
| D-dimer | D-dimer is measured by a blood test | Assessments at baseline and at 12 weeks |
| CD4+ T cell counts | CD4+ T cell counts is measured by a blood test | Assessments at baseline and at 12 weeks |
| Viral load | Viral load is measured by a blood test | Assessments at baseline and at 12 weeks |
| Functional exercise capacity | Functional exercise capacity is measured by a 6-minute walk test | Assessments at baseline and at 6 weeks |
| Flexibility | Flexibility is measured by Toe touch test and sit and reach test | Assessments at baseline and at 6 weeks |
| Lower body muscular strength | Lower body muscular strength is measured by 30-s chair-stand test | Assessments at baseline and at 6 weeks |
| Upper limb strength | Upper limb strength is measured by hand grip strength tool | Assessments at baseline and at 6 weeks |
| Quality of life | Quality of life is measured by World Health Organization Quality of Life HIV Instrument | Assessments at baseline and at 6 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |