Tai Chi Training for Elderly People With Chronic Heart Failure

May 2, 2018 updated by: Lena Hagglund, Umeå University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Vasterbotten
      • Skelleftea, Vasterbotten, Sweden, 931 87
        • Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tai Chi training
Participation in a group of 15 patients, completing a 60 minutes tai chi training programme twice-weekly for 16 weeks.
Behavioral: Tai Chi training
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.
No Intervention: Control
Living 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A self-report instrument of five dimensions of fatigue. General fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation.
after intervention of 16 weeks, at 6 months and 12 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline values of the Minnesota Living With Heart Failure Questionnaire (LHFQ)
Time Frame: after intervention of 16 weeks, at 6 months and 12 months after intervention
A self-report instrument aimed to measure the effects of symptoms, functional limitations and psychological distress on an individual´s quality of life.
after intervention of 16 weeks, at 6 months and 12 months after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the experience of participating in tai chi training
Time Frame: after completed intervention
Qualitative individual interviews
after completed intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

The Swedish Heart and Lung Association
Stiftelsen Rönnbäret
Visare Norr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 2, 2018

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tai Chi for heart failure

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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