Overview

This trial is active, not recruiting.

Condition chronic heart failure
Treatment tai chi training
Sponsor Umeå University
Collaborator Stiftelsen Ronnbaret
Start date November 2010
End date March 2012
Trial size 90 participants
Trial identifier NCT01294111, Tai Chi for heart failure

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.

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 randomized controlled clinical study is planned. Ninety 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), will be randomized to intervention or control group. Three groups with 15 participants each will complete a tai chi training programme twice-weekly for 16 weeks. Data will be 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 are 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
Participation in a group of 15 patients, completing a 60 minutes tai chi training programme twice-weekly for 16 weeks.
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)
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.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 70 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Umeå University.