Quality of LifeNCT00944788
A Structured Qi-gong Program for Hospitalized Older Adults
A study testing qi-gong in people with Quality of Life and Behavioral Symptoms, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Quality of Life, Behavioral Symptoms, Patient Compliance
- What is being tested?
- qi-gong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=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
Who cannot join
- Moderate to severe cognitive impairment (SPMSQ >= 4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Impact on Quality of Life and Depressive Symptoms of a Structured Qi-gong Program for Hospitalized Older Adults. A Pilot Study.
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.
- Conditions
- Quality of Life, Behavioral Symptoms, Patient Compliance
- Being tested
- qi-gong
- Keywords
- physical activity, aging, inpatients, quality of life, depression
- Medical subject headings
- Behavioral Symptoms, Patient Compliance, Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qi-gongOther
Physical activity similar to tai-chi
| Study group | Role | What they receive |
|---|---|---|
| qi-gong | Experimental | Not described Receives: Other: qi-gong |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 4 weeks
Secondary outcomes (2)
Depressive symptoms
Measured: 4 weeks
Adherence
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Inzitari, MD, PhD, Principal investigator, Fundació Institut Català de l'Envelliment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944788
- Sponsor's protocol ID
- FICE09071
- Other IDs
- CEEAH_UAB_792H
- Status last verified
- Jun 2013
- First submitted
- 22 Jul 2009
- Last updated
- 13 Jun 2013
- Results posted
- No
Publications
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.
PubMed 19179544Martinez 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.
PubMed 24927783
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact on Quality of Life and Depressive Symptoms of a Structured Qi-gong Program for Hospitalized Older Adults. A Pilot Study.
- ClinicalTrials.gov ID
- NCT00944788
- Acronym / sponsor ID
- FICE09071
- Conditions
- Quality of Life, Behavioral Symptoms, Patient Compliance
- Keywords
- physical activity, aging, inpatients, quality of life, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| qi-gong | Experimental | Other: qi-gong |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >=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
Key exclusion criteria (1 listed)
- Moderate to severe cognitive impairment (SPMSQ >= 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qi-gongPhysical activity similar to tai-chi | Other | qi-gong |
Primary outcome
Quality of life
Time frame: 4 weeks
2 secondary outcomes
Depressive symptoms
Time frame: 4 weeks
Adherence
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Background: PubMed 19179544Rogers 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.
- Derived from this study: PubMed 24927783Martinez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Inzitari, MD, PhD principal investigator
Fundació Institut Català de l'Envelliment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qi-gong in people with Quality of Life and Behavioral Symptoms, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00944788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.