The Effects of Home-based Physical Activity Telemonitoring Program in Patients With Heart Failure and Muscle Wasting

NCT05588375 | Unknown

• 1 other identifier: 110236-E
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Muscular Atrophy; Wasting Syndrome; Heart Failure

Keywords

Muscle Wasting; sarcopenia; physical activity; telemonitoring

Outcome Measures

Primary Outcomes (4)

• Change from baseline in hand grip at 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)

  baseline and week 12 and week 24

• Change from baseline in The five-repetition sit-to-stand test at 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)

  baseline and week 12 and week 24

• Change from baseline in six-meter walking speed test at 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)

  baseline and week 12 and week 24

• Change from baseline in Skeletal muscle mass index (SMI) at 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)

  baseline and week 12 and week 24

Secondary Outcomes (4)

• 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 (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 5-level EQ-5D version ;EQ-5D-5L) at week 12 and week 24

  baseline and week 12 and week 24

Study Arms (2)

home-based physical activity telemonitoring program

EXPERIMENTAL

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.

Behavioral: home-based physical activity telemonitoring program

walk 2-3 days a week

ACTIVE COMPARATOR

Maintain daily physical activity and lifestyle and walk for 30 minutes 2-3 days a week for three months

Behavioral: home-based physical activity telemonitoring program

Interventions

home-based physical activity telemonitoring program BEHAVIORAL

The home telehealth physical activity training program is a telemedicine physical activity training that uses Google Meet software to communicate and supervise through webcams.

home-based physical activity telemonitoring program; walk 2-3 days a week

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

RECRUITING

Related Publications (11)

• Crespo-Leiro MG, Anker SD, Maggioni AP, Coats AJ, Filippatos G, Ruschitzka F, Ferrari R, Piepoli MF, Delgado Jimenez JF, Metra M, Fonseca C, Hradec J, Amir O, Logeart D, Dahlstrom U, Merkely B, Drozdz J, Goncalvesova E, Hassanein M, Chioncel O, Lainscak M, Seferovic PM, Tousoulis D, Kavoliuniene A, Fruhwald F, Fazlibegovic E, Temizhan A, Gatzov P, Erglis A, Laroche C, Mebazaa A; Heart Failure Association (HFA) of the European Society of Cardiology (ESC). European Society of Cardiology Heart Failure Long-Term Registry (ESC-HF-LT): 1-year follow-up outcomes and differences across regions. Eur J Heart Fail. 2016 Jun;18(6):613-25. doi: 10.1002/ejhf.566.

  PMID: 27324686 BACKGROUND

• Hao G, Wang X, Chen Z, Zhang L, Zhang Y, Wei B, Zheng C, Kang Y, Jiang L, Zhu Z, Zhang J, Wang Z, Gao R; China Hypertension Survey Investigators. Prevalence of heart failure and left ventricular dysfunction in China: the China Hypertension Survey, 2012-2015. Eur J Heart Fail. 2019 Nov;21(11):1329-1337. doi: 10.1002/ejhf.1629.

  PMID: 31746111 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Tsekoura M, Kastrinis A, Katsoulaki M, Billis E, Gliatis J. Sarcopenia and Its Impact on Quality of Life. Adv Exp Med Biol. 2017;987:213-218. doi: 10.1007/978-3-319-57379-3_19.

  PMID: 28971460 BACKGROUND

• Martone AM, Bianchi L, Abete P, Bellelli G, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Marzetti E, Rizzo MR, Rossi A, Volpato S, Landi F. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study. J Cachexia Sarcopenia Muscle. 2017 Dec;8(6):907-914. doi: 10.1002/jcsm.12224. Epub 2017 Sep 14.

  PMID: 28913934 BACKGROUND

• Platz E, Jhund PS, Claggett BL, Pfeffer MA, Swedberg K, Granger CB, Yusuf S, Solomon SD, McMurray JJ. Prevalence and prognostic importance of precipitating factors leading to heart failure hospitalization: recurrent hospitalizations and mortality. Eur J Heart Fail. 2018 Feb;20(2):295-303. doi: 10.1002/ejhf.901. Epub 2017 Sep 4.

  PMID: 28872259 BACKGROUND

• von Haehling S. Muscle wasting and sarcopenia in heart failure: a brief overview of the current literature. ESC Heart Fail. 2018 Dec;5(6):1074-1082. doi: 10.1002/ehf2.12388. No abstract available.

  PMID: 30570227 BACKGROUND

• Scherbakov N, Doehner W. Cachexia as a common characteristic in multiple chronic disease. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1189-1191. doi: 10.1002/jcsm.12388. Epub 2019 Jan 13. No abstract available.

  PMID: 30637985 BACKGROUND

• Lena A, Anker MS, Springer J. Muscle Wasting and Sarcopenia in Heart Failure-The Current State of Science. Int J Mol Sci. 2020 Sep 8;21(18):6549. doi: 10.3390/ijms21186549.

  PMID: 32911600 BACKGROUND

• Valentova M, Anker SD, von Haehling S. Cardiac Cachexia Revisited: The Role of Wasting in Heart Failure. Heart Fail Clin. 2020 Jan;16(1):61-69. doi: 10.1016/j.hfc.2019.08.006.

  PMID: 31735316 BACKGROUND

• Vest AR, Chan M, Deswal A, Givertz MM, Lekavich C, Lennie T, Litwin SE, Parsly L, Rodgers JE, Rich MW, Schulze PC, Slader A, Desai A. Nutrition, Obesity, and Cachexia in Patients With Heart Failure: A Consensus Statement from the Heart Failure Society of America Scientific Statements Committee. J Card Fail. 2019 May;25(5):380-400. doi: 10.1016/j.cardfail.2019.03.007. Epub 2019 Mar 13.

  PMID: 30877038 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Wasting Syndrome; Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Heng-Hsin Tung

  School of Nursing, National Yang Ming Chiao Tung University

  STUDY CHAIR

Central Study Contacts

Shu-Wen Chang

CONTACT

886277282152; irb@mail.femh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants received cases in independent clinics, and patients, attending physicians and nursing staff did not know the group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a quasi-experimental, two-group repeated measurement design, purposive sampling. The experimental group received the Home-based exercise with telemonitoring and control group according to regular nursing care.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. Data were collected at baseline (T0), post-tests will be conducted right after the intervention period (T1). Additionally, detraining effects will be measured 12 weeks after program cessation (T2).

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: October 20, 2022
• Study Start: April 21, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: October 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)