The Effects of Home-based Physical Activity Telemonitoring Program in Patients With Heart Failure and Muscle Wasting in the Post-epidemic Era
试验速览
- 阶段
- 不适用
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change from baseline in The five-repetition sit-to-stand test at week 12 and week 24
研究概览
简要总结
Introduction： Muscle wasting is a serious complication that affects a large proportion of patients with heart failure (HF). Muscle wasting is a strong predictor of frailty and reduced survival in HF patients. Currently, standard treatments for slowing muscle loss in patients with HF are not available. The main intervention remains various types of physical activity programs. Telemonitoring is a promising strategy for improving heart failure outcomes by making it possible to monitor patients remotely. There are numerous examples of home-based exercise programs administered through telehealth services that have been beneficial for maintaining physical activity levels. These results highlight the potential utility of telehealth services for combatting sedentarism and muscle wasting among epidemic and post-epidemic phases.
Objective： The purpose of this study is to evaluate the effect of a multi-component physical activity program based on home telemonitoring on patients with heart failure and muscle wasting. Methods： This study used an quasi-experimental study, two-group repeated measurement design. The experimental group received the Home-based exercise with telemonitoring and control group according to regular nursing care. Data were collected at baseline (T0), and post-tests will be conducted right after the intervention period (T1). Additionally, detraining effects will be measured 12 weeks after program cessation (T2) . Data were collected including demographic questionnaire, sarcopenia, cachexia assessment, clinical blood parameters from patient record, physical activity, loneliness, and quality of life.
Scientific or Clinical Implication of the Expected Results： The study results can be used to design designated interventions and provide information for policymaking.
详细描述
This study adopts an quasi-experimental study, two-group repeated-measures research design, purposive sampling, and after baseline assessment. Both the experimental group and the control group were patients included in the case management of heart failure in the hospital. The experimental group received 59 cases who participated in remote home sports, and the control group received 59 cases who received routine care for heart failure case management.
In this study, G power 3.1.9.7 software was used, and ANOVA: Repeated measures, between factors was selected to calculate the sample size, and the G power program (Faul et al., 2007) was used to estimate the appropriate sample size, according to previous group and family exercise programs. Results of a study of outcomes in patients with sarcopenia (Tsekoura et al., 2017), each group required 28 participants to measure grip strength between the intervention and control groups (SD = 4.2), equivalent to an effect size of 0.316, significant level α=0.05, test force β=0.95. The estimated potential attrition rate is 30%, and 118 cases are expected to be accepted, requiring 59 subjects per
Method of recruitment:
Patients with mild to moderate and stable systolic heart failure who met the NYHA first-to-third definition of the New York Heart Association were first screened from the medical records, and the outpatient physicians or nurses introduced this study to potential subjects during routine return visits. After obtaining their consent, the researchers contacted them again, and after obtaining consent, they reviewed their medical records to recruit research subjects. After reviewing the acceptance and exclusion conditions, the research purpose and explanation were carried out. After the participants agreed, the study list was included in the study. on the roster for receipt.
4.How subjects consented: The outpatient physician or nurse practitioner will introduce the study to potential subjects, and after obtaining their consent, the researcher will review the medical records and then recruit the subjects, explain the research purpose and research process, inform the participants of their rights, and the subjects who are willing to participate are invited to fill in the research consent form before closing the case.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
All participants received cases in independent clinics, and patients, attending physicians and nursing staff did not know the group assignment
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate and stable systolic heart failure as defined by the New York Heart Association NYHA Class I to III;
- •Resting left ventricular ejection fraction (LVEF) ≤ 50%;
- •Over 20 years old;
- •Be able to communicate in Chinese and Taiwanese and participate in the research voluntarily;
- •cases consistent with sarcopenia, cachexia, or both.
排除标准
- •Cognitive dysfunction or psychiatric disturbance (based on medical records);
- •Patients with tumors;
- •Signs of acute infection two months ago;
- •Severe knee or back pain;
- •Severely impaired mobility;
- •Engaged in exercise training within the past 3 months;
- •Hospitalization for CHF or change in CHF therapy within 1 month, unstable angina, fixed cardiac pacemaker;
- •Inability to use a smartphone (including those without internet access or unable to operate communication software such as Line and Google Meet).
研究组 & 干预措施
home-based physical activity telemonitoring program
The home telehealth physical activity training program is a telemedicine physical activity training that uses Google Meet software to communicate and supervise through webcams. The exercise process is supervised and guided by a trained critical care nurse. The experimental group participated in a telehealth physical activity training program. The telemedicine physical activity training program included a 3-month online intervention (exercise diary, exercise training education, and 24 exercise sessions for patients) and a 3-month follow-up after exercise.
干预措施: home-based physical activity telemonitoring program (Behavioral)
walk 2-3 days a week
Maintain daily physical activity and lifestyle and walk for 30 minutes 2-3 days a week for three months
干预措施: home-based physical activity telemonitoring program (Behavioral)
结局指标
主要结局
Change from baseline in The five-repetition sit-to-stand test at week 12 and week 24
时间窗: baseline and week 12 and week 24
The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times. Change =(Week 12 score-baseline score; week 24 score-baseline score)
Change from baseline in hand grip at week 12 and week 24
时间窗: baseline and week 12 and week 24
Measured with a Jamar Hydraulic Hand Dynamometer(kg). This hand dynamometer is ideal for routine screening of grip strength and hand function. This hand strength test also features a dual-scale readout displaying isometric grip force from 0 - 90kg.(M\<28kg; Female\<18kg for low grip strength) Change =(Week 12 score-baseline score; week 24 score-baseline score)
Change from baseline in six-meter walking speed test at week 12 and week 24
时间窗: baseline and week 12 and week 24
In order to obtain accurate data, an acceleration zone and a deceleration zone of 1.5 m. Measure the time it takes the patient to actually walk six meters. The score is the amount of time (to the nearest decimal in seconds)meters are given before and after the measurement zone. Change =(Week 12 score-baseline score; week 24 score-baseline score)
Change from baseline in Skeletal muscle mass index (SMI) at week 12 and week 24
时间窗: baseline and week 12 and week 24
The SMI was calculated by dividing the limb skeletal muscle mass (kg) by the square of the height (m 2). Determined by bioelectrical impedance analysis ( for males with SMI \<7.0 kg/m2 and females with SMI \<5.7 kg/m2). Change =(Week 12 score-baseline score; week 24 score-baseline score)
次要结局
- Change from baseline in (Mini Nutritional Assessment-Short Form;MNA-SF) at week 12 and week 24(baseline and week 12 and week 24)
- Change from baseline in loneliness(3-item loneliness scales) at week 12 and week 24(baseline and week 12 and week 24)
- Change from baseline in the international physical activity questionnaire - short form; IPAQ-SF at week 12 and week 24(baseline and week 12 and week 24)
- Change from baseline in (The 5-level EQ-5D version ;EQ-5D-5L) at week 12 and week 24(baseline and week 12 and week 24)