NCT00944788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

July 22, 2009

Last Update Submit

June 12, 2013

Conditions

Keywords

physical activityaginginpatientsquality of lifedepression

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    4 weeks

Secondary Outcomes (2)

  • Depressive symptoms

    4 weeks

  • Adherence

    4 weeks

Study Arms (2)

qi-gong

EXPERIMENTAL
Other: qi-gong

Usual care

NO INTERVENTION

Interventions

qi-gongOTHER

Physical activity similar to tai-chi

qi-gong

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=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

You may not qualify if:

  • Moderate to severe cognitive impairment (SPMSQ \>= 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Sanitari Pere Virgili

Barcelona, 08023, Spain

Location

Related Publications (2)

  • Rogers CE, Larkey LK, Keller C. A review of clinical trials of tai chi and qigong in older adults. West J Nurs Res. 2009 Mar;31(2):245-79. doi: 10.1177/0193945908327529.

    PMID: 19179544BACKGROUND
  • Martinez N, Martorell C, Espinosa L, Marasigan V, Domenech S, Inzitari M. Impact of Qigong on quality of life, pain and depressive symptoms in older adults admitted to an intermediate care rehabilitation unit: a randomized controlled trial. Aging Clin Exp Res. 2015 Apr;27(2):125-30. doi: 10.1007/s40520-014-0250-y. Epub 2014 Jun 14.

MeSH Terms

Conditions

Behavioral SymptomsPatient ComplianceMotor ActivityDepression

Interventions

Qigong

Condition Hierarchy (Ancestors)

BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marco Inzitari, MD, PhD

    Fundació Institut Català de l'Envelliment

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations