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
  Purpose

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 Intervention
HIV Infections
AIDS
Procedure: Massage therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Massage to Enhance Well-Being in HIV-Positive Dominican Children

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 54
Study Start Date: March 2003
Estimated Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070980

Locations
Dominican Republic
CENISMI/Robert Reid Cabral Children's Hospital
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Investigators
Principal Investigator: Gail Shor-Posner, MD University of Miami
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00070980     History of Changes
Other Study ID Numbers: R21 AT001160-01A1
Study First Received: October 9, 2003
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Complementary Therapies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014