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Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070980
Recruitment Status : Completed
First Posted : October 13, 2003
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

Condition or disease Intervention/treatment Phase
HIV Infections AIDS Procedure: Massage therapy Not Applicable

Detailed Description:

The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic.

Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Massage to Enhance Well-Being in HIV-Positive Dominican Children
Study Start Date : March 2003
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infection
  • Parent/caregiver signature on consent form

Exclusion criteria:

  • Unknown HIV status
  • Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry
  • Massage therapy within 30 days prior to study entry
  • Unable to have massage (e.g., extensive skin lesions)
  • Symptoms of child abuse
  • Child born drug-addicted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070980

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Dominican Republic
CENISMI/Robert Reid Cabral Children's Hospital
Santo Domingo, Dominican Republic
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Gail Shor-Posner, MD University of Miami
Layout table for additonal information Identifier: NCT00070980    
Other Study ID Numbers: R21AT001160-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2003    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: July 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Complementary Therapies
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases