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A Structured Qi-gong Program for Hospitalized Older Adults

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ClinicalTrials.gov Identifier: NCT00944788
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Fundacio Salut i Envelliment UAB

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 23, 2009
Last Update Posted Date June 13, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Quality of life [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00944788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
  • Depressive symptoms [ Time Frame: 4 weeks ]
  • Adherence [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Structured Qi-gong Program for Hospitalized Older Adults
Official Title  ICMJE Feasibility and Impact on Quality of Life and Depressive Symptoms of a Structured Qi-gong Program for Hospitalized Older Adults. A Pilot Study.
Brief Summary The purpose of this study is to test the effects on a number of health outcomes and the feasibility of a structured program of qi-gong, a form of tai-chi which has been previously tested in older populations, in older hospitalized patients. In particular, this pilot study aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment, with the hypothesis that this intervention will have a positive impact on these two domains, compared to usual care. Adherence will be also monitored in the intervention arm.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Quality of Life
  • Behavioral Symptoms
  • Patient Compliance
Intervention  ICMJE Other: qi-gong
Physical activity similar to tai-chi
Study Arms  ICMJE
  • Experimental: qi-gong
    Intervention: Other: qi-gong
  • No Intervention: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2013)
58
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2009)
50
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >=50 years old
  • Preserved ability to move inside the house (also using walking aids or chair)
  • Estimation of at least one month of hospitalization (convalescence or rehabilitation)
  • Ability and willing to sign informed consent

Exclusion Criteria:

  • Moderate to severe cognitive impairment (SPMSQ >= 4)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944788
Other Study ID Numbers  ICMJE FICE09071
CEEAH_UAB_792H
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacio Salut i Envelliment UAB
Study Sponsor  ICMJE Fundacio Salut i Envelliment UAB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Inzitari, MD, PhD Fundació Institut Català de l'Envelliment
PRS Account Fundacio Salut i Envelliment UAB
Verification Date June 2013

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