Tai Chi Training for Elderly People With Chronic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Umeå University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stiftelsen Ronnbaret
Hjart och Lungsjukas riksforbund
Visare Norr
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01294111
First received: January 3, 2011
Last updated: February 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Behavioral: Tai Chi training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A self-report instrument of five dimensions of fatigue. General fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A self-report instrument aimed to measure the effects of symptoms, functional limitations and psychological distress on an individual´s quality of life.


Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294111

Locations
Sweden
Umea University
Skelleftea, Vasterbotten, Sweden, 931 87
Sponsors and Collaborators
Umeå University
Stiftelsen Ronnbaret
Hjart och Lungsjukas riksforbund
Visare Norr
  More Information

No publications provided

Responsible Party: Lena Hagglund / RNT, PhD, Umea University, Department of Nursing
ClinicalTrials.gov Identifier: NCT01294111     History of Changes
Other Study ID Numbers: Tai Chi for heart failure
Study First Received: January 3, 2011
Last Updated: February 10, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Fatigue
Quality of life
Elderly

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014