Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With HF and Their Caregivers: a Randomized Controlled Trial

Официальное название

A Randomized Controlled Trial to Evaluate the Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With Heart Failure (HF) and Their Caregivers.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое HDTC 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, demonstrati
• Другое Usual 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.

Первичные конечные точки

• functional capacity of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 weeks and 12 weeks]
• cardiac function of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 weeks and 12 weeks]

Вторичные конечные точки (9)

• sedentary behavior of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• Fear of Activity of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• Exercise self-efficacy of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• hospital admission of CHF individuals [Срок оценки: From enrollment to the end of intervention at 12 weeks]
• Health-related QoL of CHF individuals [Срок оценки: From enrollment to the end of intervention at 4 and12 weeks]
• care burden of caregivers [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• QoL of caregivers [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• mutuality of CHF-caregiver dyads [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]
• depression, anxiety, and stress of CHF-caregiver dyads [Срок оценки: From enrollment to the end of intervention at 4 and 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Affiliated Hospital of Qingdao University — Qingdao

Публикации

• Zhang Y, Ngai FW, Wei L, Lu X, Liang J, Xie YJ. Effects of home-based digital-assisted dyadic Tai Chi training in Chinese chronic heart failure patients and family caregivers: a randomised controlled trial protocol. BMJ Open. 2026 Apr 28;16(4):e114352. doi: 10.1136/bmjopen-2025-114352. PMID 42049291

Идентификаторы

NCT: NCT06876441 · HSEARS20240904005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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