Heart Failure (HF)
Conditions
Keywords
heart failure, Tai Chi, dyadic, cardiac function, care burden
Brief summary
The full scale RCT aims to assess the effectiveness of the HDTC training program in improving functional capacity, cardiac function and secondary outcomes among sedentary chronic heart failure (CHF) individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.
Detailed description
The full scale RCT is a two-arm parallel, single-blinded randomized controlled trial. A total of 128 CHF individuals and 128 caregivers will be enrolled and allocated to the HDTC group and the control group in a 1:1 ratio. Participants in the control group will receive usual care. Those in the HDTC group will attend usual care plus the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, a preliminary Tai Chi training session, and 12-week Tai Chi training. Data on functional capacity, cardiac function, exercise self-efficacy, fear of activity, sedentary behavior, hospital admission, health-related quality of life, depression, anxiety, stress, and mutuality for HF individuals, as well as care burden, quality of life, depression, anxiety, stress, and mutuality of caregivers, will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after the intervention. The intention-to-treat analysis (ITT), modified ITT analysis, and per-protocol analysis will be conducted. The generalized estimating equation (GEE) model will be used to measure changes in outcome variables.
Interventions
BEHAVIORALHDTC training program
Participants will receive usual care plus HDTC training program, including four parts: (1)30-minute educational seminar via WeChat: provide disease knowledge, propose strategies to replace sedentary behavior, and introduce Tai Chi. (2)1-hour online nurse-lead dyadic coaching session: introduce dyadic Tai Chi, clarify the roles and responsibilities, and establish a shared goal among dyads. (3)1-hour preliminary Tai Chi training session: face-to-face, introduce online Tai Chi learning, demonstrations on using heart rate monitor. (4)12-week Tai Chi training: Dyads learn Tai Chi following Tai Chi master online. The frequency gradually increased from 2 to 3 classes per week and duration extending from 30 to 50 minutes. Subsequently, they will practice Tai Chi with the master twice a week and slef-practce follow instructional videos once a week, with each session lasting 50 minutes.
OTHERUsual Care Group
CHF-caregiver dyads in the control group will receive the usual care, including a 30-min online comprehensive education and nurse-led support through telephone consultations in the aspects of symptom management, medication, dietary and exercise suggestions, psychosocial support, and regular monthly follow-up every month.
Sponsors
The Hong Kong Polytechnic University
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* CHF individuals: * aged 18 to 75 years * diagnosed with CHF, regardless of the HF phenotype (HFrEF, HFmrEF, and HFpEF) * categorized as NYHA class I, II or III * 6MWD \>150 meters (mild to moderate HF) * stable phase of disease in the past four weeks and capable of independently practice Tai Chi without any musculoskeletal disorders that may impede joint movement * sit more than 8 h/d in the past month * own a smartphone * volunteer to participate and provide informed consent. * caregivers: * age ≥18 years old * primary caregiver at home, who has emotional ties or social obligations with CHF individuals and provides daily care * able to exercise Tai Chi without help * volunteer to participate and provide informed consent.
Exclusion criteria
* HF individuals: * plan to undergo surgery within the next 6 months * have severe comorbidities, such as cancer, liver or kidney failure, or diagnosed psychiatric disorders * plan to be admitted to a nursing home or other care facilities * regularly practice Tai Chi or engaging in other forms of exercise in the past 3 months (at least 3 times per week, at least 20 minutes of regular exercise each time) * currently participate in similar or related studies. * caregivers: · formal caregivers, such as nurses, will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional capacity of CHF individuals | From enrollment to the end of intervention at 4 weeks and 12 weeks | The six-minute walking test (6MWT) will be used to assess exercise tolerance of CHF individuals (LVEF reduced or not) |
| cardiac function of CHF individuals | From enrollment to the end of intervention at 4 weeks and 12 weeks | Another primary outcome of this study is the cardiac function of those CHF individuals with HFrEF and HFmrEF, measured by LVEF. LVEF is a crucial parameter for assessing cardiac function. It is an echocardiographic measure that reflects cardiac function by indicating the percentage of blood ejected from the left ventricle with each heartbeat. Three-dimensional echocardiography will be employed to measure LVEF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedentary behavior of CHF individuals | From enrollment to the end of intervention at 4 and 12 weeks | CHF individuals' sedentary behavior will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). |
| Fear of Activity of CHF individuals | From enrollment to the end of intervention at 4 and 12 weeks | Fear of Activity in Patients with Chronic Heart Failure (Fact-CHF) will be used to assess HF patients' fear of exercise. This scale consists of 15 items, using a 5-point Likert scale where 0 represents 'never' and 4 represents 'always'. The total score ranges from 0 to 60, with higher scores indicating higher levels of fear. |
| Exercise self-efficacy of CHF individuals | From enrollment to the end of intervention at 4 and 12 weeks | Exercise self-efficacy will be assessed utilizing the Self-Efficacy for Exercise Scale (SEE) , which specifically measures an individual's confidence in performing exercise despite various barriers. The scale consists of 9 items with scores ranging from 0 to 90, with higher score indicating greater confidence in participating in exercise activities. |
| hospital admission of CHF individuals | From enrollment to the end of intervention at 12 weeks | CHF individual's hospital admission status will be presented based on the number of hospital admissions during the intervention period, including emergency visits. |
| Health-related QoL of CHF individuals | From enrollment to the end of intervention at 4 and12 weeks | Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a specific and commonly used scale for measuring QoL among HF patients, which will be used to assess QoL. |
| care burden of caregivers | From enrollment to the end of intervention at 4 and 12 weeks | The Chinese version of the Zarit Caregiver Burden Interview (ZBI), will be used to measure caregivers' perceived burden of providing care. |
| QoL of caregivers | From enrollment to the end of intervention at 4 and 12 weeks | The Family Caregiver Quality of Life (FAMQOL) is a specific instrument designed by Nauser in 2011 to assess the QoL among caregivers of HF patients. |
| mutuality of CHF-caregiver dyads | From enrollment to the end of intervention at 4 and 12 weeks | Mutuality, is a dyadic-level variable influencing caregiver's contribution to CHF self-care, with a good relationship improving the dyadic health of both patients and caregivers. The Mutuality Scale (MS) will be used, containing 15 items categorized into four dimensions: love and affection, shared values, shared enjoyable activities, and reciprocity. Responses are rated using a 5-point Likert type (0=not at all, 4=quite a lot). The mean item score will be computed as the final score, ranging from 0 to 4, with a higher score denoting better mutuality. |
| depression, anxiety, and stress of CHF-caregiver dyads | From enrollment to the end of intervention at 4 and 12 weeks | The Depression Anxiety Stress Scales-21 (DASS-21) will be used to assess the severity of psychological distress about depression, anxiety, and stress over the preceding week of both CHF patients and their caregivers. Each of the three DASS-21 subscales contains 7 items, with a total of 21 items. A Likert scale ranging from 0 to 3 is employed, with recommended cut-off scores of 9, 7, and 14 for depression, anxiety, and stress, respectively. The higher the score, the higher the level of anxiety, depression, and stress. |
Countries
China
Contacts
CONTACTYao Jie Xie, PhD
CONTACTYan Zhang, Master
Outcome results
None listed