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Chronic Heart FailureNCT01294111

Tai Chi Training for Elderly People With Chronic Heart Failure

A study testing Tai Chi training in people with Chronic Heart Failure, run by Umeå University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Physical activity is recommended in the treatment of heart failure. Elderly people demand various forms of physical activity. Tai chi has shown to be an appreciated form of physical activity among elderly, although there is a lack of studies focusing people aged 70 years and older. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
Tai Chi training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSweden
Study dates
Nov 2010to 2 May 2018
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Verified diagnosis of heart failure
  • Left ventricle ejection fraction < 50
  • Stable medical treatment with Angiotensin Converting Enzyme blockers and Betareceptor blockers (if no contraindications) experience of fatigue according to the Multidimensional Fatigue Inventory
  • 70 years or older
  • Swedish speaking

Who cannot join

  • Instable angina pectoris
  • Myocardial infarction within the last three months
  • Cognitive impairment
  • No experienced fatigue

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Umea University

    Skellefteå, Västerbotten County, 931 87

Other trials in Sweden

About this study

Physical activity is recommended in the treatment of heart failure. Elderly people demand various forms of physical activity. Tai chi has shown to be an appreciated form of physical activity among elderly, although there is a lack of studies focusing people aged 70 years and older.

The overall goal with the project is to find a form of physical activity that is safe and free from side effects, suitable for elderly people with chronic heart failure. The hypothesis is that for patients participating in tai chi training during three months the degree of self rated fatigue will be reduced and health-related quality of life will increase, compared with a control group receiving ordinary care. The primary aim is to study the effect of tai chi training on fatigue and health-related quality of life. A second aim is to study effects on physical function and levels of brain natriuretic peptide (BNP) in blood plasma. A tertiary aim is to describe the experience of participating in tai chi training.

Read more

A mixed methods study is conducted. Fortyfive patients with a verified diagnosis of heart failure in the age of 70 years or older, who experience fatigue according to the Multi Fatigue Inventory (MFI-20), was randomized to intervention or control group. Three groups with 8-9 participants each completed a tai chi training programme twice-weekly for 16 weeks. Data was collected at baseline, directly after the 16 weeks of training, and 6 and 12 months thereafter. The programme is worked out by an expert in Chinese traditional medicine to suit elderly people with chronic heart failure, and the classes were led by experienced leaders. Before the start of the study a small pilot study was conducted to test the feasibility of the programme. A group of seven patients completed the programme for eight weeks without any problems.

If tai chi has a good effect on fatigue, health-related quality of life and physical function, this form of physical activity can be a valuable complement to other medical treatment. Tai chi has a potential to be offered to many patients to a relatively low cost. It can be practiced in groups or in private, and also through internet connection.

Being tested
Tai Chi training
Keywords
Fatigue, Quality of life, Elderly
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Chi trainingBehavioural

    Three groups with 15 participants each will complete a 60 minutes tai chi training programme twice-weekly for 16 weeks. The programme is worked out by an expert in Chinese traditional medicine to suit elderly people with chronic heart failure, and the classes are led by experienced leaders.

Study groups in NCT01294111
Study groupRoleWhat they receive
Tai Chi trainingExperimentalParticipation in a group of 15 patients, completing a 60 minutes tai chi training programme twice-weekly for 16 weeks.
Receives: Behavioral: Tai Chi training
ControlNo interventionLiving as usual, following ordinary care plans and personal activities. Participants will be called to hospital for data collection. Participants are asked not to start any of the activities Tai Chi, Qui Gong or Yoga during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline values of the Multidimensional Fatigue Inventory, MFI-20

    A self-report instrument of five dimensions of fatigue. General fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation.

    Measured: after intervention of 16 weeks, at 6 months and 12 months after intervention

Secondary outcomes (1)

  1. Changes from baseline values of the Minnesota Living With Heart Failure Questionnaire (LHFQ)

    A self-report instrument aimed to measure the effects of symptoms, functional limitations and psychological distress on an individual´s quality of life.

    Measured: after intervention of 16 weeks, at 6 months and 12 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2012
  4. Study completion2 May 2018

Resources

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
Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01294111
Sponsor's protocol ID
Tai Chi for heart failure
Status last verified
May 2018
First submitted
3 Jan 2011
Last updated
8 May 2018
Results posted
No

Publications

  • Barrow DE, Bedford A, Ives G, O´Toole LO, & Channer KS (2007). An evaluation of the effects of Tai Chi Chuan and Chi Kung training in patients with symptomatic heart failure: a randomised controlled pilot study. Postgrad Med, 83,717-721. Cheng TO (2007). Tai Chi: The Chinese ancient wisdom of an ideal exercise for cardiac patients. Int J Cardiol, 117, 293-295. (editorial) Dolansky MA, Moore SM, & Visovsky C (2006). Older adults´ views of cardiac rehabilitation programs. J Gerontol Nurs, 32(2), 37-44. Hägglund, L., Boman, K., Stenlund, H., Lundman, B., & Brulin, C. (2008). Factors related to fatigue among older patients with heart failure in primary health care. Int J Older People Nurs, 3(2), 96-103. Motivala SJ, Sollers J, Thayer J & Irwin MR (2006). Tai Chi Chih acutely decreases sympathetic nervous system activity in older adults. J Ger A Bio Sci Med, 61(11), 1177-1180. Rector TS, Kubo SH, & Cohn JN (1987). Patients´self-assessment of their congestive heart failure: Part 2: Content, reliability and validity of a new measure, The Minnesota Living with Heart Failure Questionnaire. Heart Fail, 3, 198-209. Rees K, Taylor RS, Singh S, Coats AJS, & Ebrahim S (2004). Exercise based rehabilitation for heart failure. Cochrane Database of Systematic Reviews, (3) Art.No.: CD003331. DOI: 10.1002/14651858.CD003331.pub2. Smets EMA, Garssen B, Bonke B, de Haes JCJM. 1995. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res, 39 (5), 315-25. Verhagen AP, Immink M, van der Meulen A, & Bierma-Zeinstra SMA (2004). The efficacy of Tai Chi Chuan in older adults: a systematic review. Fam Pract, 21, 107-113. Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, & Phillips RS. (2004). Effects of Tai Chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: A randomized controlled trial. Am J Med, 117, 541-548.

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi training in people with Chronic Heart Failure, run by Umeå University at 1 site in Sweden.

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 5 inclusion and 4 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 8 May 2018. 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 Sweden. 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?

Changes from baseline values of the Multidimensional Fatigue Inventory, MFI-20 (time frame: after intervention of 16 weeks, at 6 months and 12 months after intervention). 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 NCT01294111, which also lists 1 linked publication.

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 8 May 2018.

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