High-technology TeleRehabilitation for the Treatment of the FRAgile Patient
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in VO#max from baseline to 8 weeks
研究概览
简要总结
The aim of this randomized controlled clinical trial is to evaluate the efficacy of an 8-week sensorimotor and cognitive telerehabilitation program in frail and pre-frail older adults with stable chronic heart failure. The study will compare a synchronous telerehabilitation intervention with a caregiver-supervised home exercise program. The primary question is whether telerehabilitation improves functional capacity, measured by change in peak oxygen uptake (VO₂peak) on cardiopulmonary exercise testing, more than the control intervention. A key secondary question is whether telerehabilitation improves frailty status, measured by the Italian Frailty Index (IFI), compared with the control group. Secondary outcomes include quality of life, physical performance, cognitive function, treatment adherence, caregiver burden and stress, and selected biomarkers related to heart failure and frailty. Participants will undergo baseline and follow-up clinical, functional, cognitive, and laboratory assessments and will be followed for up to 24 weeks.
详细描述
Frailty is a multidimensional condition associated with reduced physiological reserve, vulnerability to stressors, loss of functional capacity, and increased risk of hospitalization and dependency. In patients with chronic heart failure, frailty is highly prevalent and is associated with worse prognosis, lower exercise tolerance, poorer quality of life, and increased caregiver burden. Telerehabilitation may represent a scalable strategy to extend rehabilitation beyond hospital-based settings, improve continuity of care, and support safe home-based management in older adults with limited access to conventional services.
Frailty is a multidimensional condition associated with reduced physiological reserve, vulnerability to stressors, loss of functional capacity, and increased risk of hospitalization and dependency. In patients with chronic heart failure, frailty is highly prevalent and is associated with worse prognosis, lower exercise tolerance, poorer quality of life, and increased caregiver burden. Telerehabilitation may represent a scalable strategy to extend rehabilitation beyond hospital-based settings, improve continuity of care, and support safe home-based management in older adults with limited access to conventional services. This study is designed to evaluate whether a structured sensorimotor and cognitive telerehabilitation program provides greater benefit than a caregiver-supervised home exercise program in older adults with stable chronic heart failure and pre-frailty or frailty. The intervention is delivered over 8 weeks through a synchronous digital platform with remote clinical supervision and physiologic monitoring, while the control group performs an individualized home-based program with caregiver support. The study focuses on functional capacity as the main efficacy domain, with additional evaluation of frailty status, quality of life, cognitive performance, treatment adherence, caregiver burden, and selected biomarkers associated with heart failure and frailty. Follow-up assessments are included to explore whether any treatment effects are maintained over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Where applicable, endpoint assessment/extraction will be performed by personnel not involved in delivering the intervention, and the statistical analysis will be conducted on an anonymized dataset.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older.
- •Diagnosis of chronic heart failure for at least 6 months, on stable optimal medical therapy for at least 1 month, regardless of systolic function classification (HFrEF, HFmrEF, or HFpEF), and in NYHA class I-III.
- •Pre-frailty or frailty documented by validated instruments, defined by at least one of the following: Fried phenotype: pre-frailty (1-2 criteria) or frailty (3 or more criteria); Italian Frailty Index (IFI): score ≥1;
- •Short Physical Performance Battery (SPPB):
- •total score 5-9/12, consistent with functional frailty; or total score 10/12, consistent with pre-frailty if the reduction is attributable to the sit-to-stand test, as documented in the case report form.
- •Ability to provide written informed consent, or availability of a legally authorized representative when applicable.
- •Availability of a caregiver, when required for participation in the rehabilitation program.
排除标准
- •Age younger than 65 years.
- •NYHA class IV and/or high likelihood of heart transplantation or ventricular assist device (VAD) implantation within 6 months after screening.
- •Absence of pre-frailty/frailty, defined as:
- •Fried phenotype = 0 criteria, and IFI = 0, and SPPB ≥ 11/12 (or 10/12 without evidence of impairment in the sit-to-stand component according to the predefined criterion).
- •Severe renal impairment (estimated glomerular filtration rate eGFR <30 mL/min/1.73 m²) or dialysis.
- •Inability to walk independently, even with assistive devices. SPPB total score <5/12, indicating severe functional impairment not compatible with safe execution of the study protocol, regardless of IFI or Fried criteria.
- •Other serious diseases substantially limiting life expectancy (for example, end-stage cancer or end-stage lung disease).
- •Severe visual impairment preventing completion of study procedures even with caregiver support and reasonable accommodations.
- •Current or suspected pregnancy.
研究组 & 干预措施
TELEREHABILITATION
Participants assigned to this arm will receive an 8-week individualized sensorimotor and cognitive telerehabilitation program delivered through a synchronous digital platform. The intervention includes motor training and cognitive training tailored to the participant's frailty level, with continuous remote monitoring of vital signs, including ECG, heart rate, oxygen saturation, and blood pressure. Participants and caregivers will receive initial training and technical support.
干预措施: Telerehabilitation (Behavioral)
Caregiver-Supervised Home Exercise
Participants assigned to this arm will receive an 8-week individualized home-based sensorimotor and cognitive exercise program matched to the participant's frailty profile. The program will be explained in person and then continued at home under caregiver or family supervision. Participants will perform the same general categories of motor and cognitive exercises as the intervention group and will record activities in a daily diary, with monitoring of heart rate, oxygen saturation, and blood pressure according to study procedures.
干预措施: Caregiver-Supervised Home Exercise Program (Behavioral)
结局指标
主要结局
Change in VO#max from baseline to 8 weeks
时间窗: Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)
Functional capacity will be assessed as the change in peak oxygen uptake (VO₂peak, mL/kg/min) measured by cardiopulmonary exercise testing (CPET). The primary efficacy analysis will compare VO₂peak at 8 weeks between the telerehabilitation group and the control group, adjusted for baseline values.
次要结局
- Change in Italian Frailty Index (IFI)(Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks)
- Change in Short Physical Performance Battery (SPPB) Score(Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks)
- Change in Quality of Life Assessed by Short Form-36 (SF-36)(Baseline, 8 weeks, and 24 weeks)
- Change in Mini-Mental State Examination (MMSE) Score(Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks)
- Change in Montreal Cognitive Assessment (MoCA) Score(Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks)
- Biochemical Parameters(Baseline, 8 weeks, and 24 weeks)
- Change in Biochemical Parameters(Baseline, 8 weeks, and 24 weeks)
- Change in Zarit Burden Interview-12 (ZBI-12) Score(Baseline and 8 weeks)
- Change in Perceived Stress Scale-10 (PSS-10) Score(Baseline and 8 weeks)
- System Usability Scale (SUS) Score(8 weeks)
- Treatment Adherence(Throughout the 8-week intervention period)
研究者
Alessia Bramanti
Associate Professor
University of Salerno