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Completed

NCT Number: NCT01294111

Tai Chi Training for Elderly People With Chronic Heart Failure

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umea University

Skellefteå, Västerbotten County, 931 87, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. To describe the experience of participating in tai chi training

    Time frame: after completed intervention

    Qualitative individual interviews

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Stiftelsen Ronnbaret
  • The Swedish Heart and Lung Association
  • Visare Norr

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2018
First posted
Feb 11, 2011
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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