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

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00070980
First received: October 9, 2003
Last updated: August 17, 2006
Last verified: July 2006

October 9, 2003
August 17, 2006
March 2003
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Complete list of historical versions of study NCT00070980 on ClinicalTrials.gov Archive Site
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Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Massage to Enhance Well-Being in HIV-Positive Dominican Children

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Procedure: Massage therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2004
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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
Both
3 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
Dominican Republic
 
NCT00070980
R21 AT001160-01A1
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Gail Shor-Posner, MD University of Miami
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP