Tai Chi Training for Elderly People With Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tai Chi training
Sponsored by

About this trial
This is an interventional supportive care trial for Chronic Heart Failure focused on measuring Fatigue, Quality of life, Elderly
Eligibility 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
Sites / Locations
- Umea University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tai Chi training
Control
Arm Description
Participation in a group of 15 patients, completing a 60 minutes tai chi training programme twice-weekly for 16 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01294111
First Posted
January 3, 2011
Last Updated
May 2, 2018
Sponsor
Umeå University
Collaborators
Stiftelsen Ronnbaret, The Swedish Heart and Lung Association, Visare Norr
1. Study Identification
Unique Protocol Identification Number
NCT01294111
Brief Title
Tai Chi Training for Elderly People With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Stiftelsen Ronnbaret, The Swedish Heart and Lung Association, Visare Norr
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Fatigue, Quality of life, Elderly
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi training
Arm Type
Experimental
Arm Description
Participation in a group of 15 patients, completing a 60 minutes tai chi training programme twice-weekly for 16 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi training
Intervention Description
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 Outcome Measure Information:
Title
Changes from baseline values of the Multidimensional Fatigue Inventory, MFI-20
Description
A self-report instrument of five dimensions of fatigue. General fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation.
Time Frame
after intervention of 16 weeks, at 6 months and 12 months after intervention
Secondary Outcome Measure Information:
Title
Changes from baseline values of the Minnesota Living With Heart Failure Questionnaire (LHFQ)
Description
A self-report instrument aimed to measure the effects of symptoms, functional limitations and psychological distress on an individual´s quality of life.
Time Frame
after intervention of 16 weeks, at 6 months and 12 months after intervention
Other Pre-specified Outcome Measures:
Title
To describe the experience of participating in tai chi training
Description
Qualitative individual interviews
Time Frame
after completed intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Umea University
City
Skelleftea
State/Province
Vasterbotten
ZIP/Postal Code
931 87
Country
Sweden
12. IPD Sharing Statement
Citations:
Citation
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.
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Tai Chi Training for Elderly People With Chronic Heart Failure
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