The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years

Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older

Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of the device for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported the system were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the device training would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older patients aged 80 years and over.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610064
      • Recruiting
      • West China Hospital,Sichuan University
      • Contact: Yuxiang Liang; Phone Number: 0086-13982250862; Email: yx45liang@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
• Agree to participant this study and sign the informed consent
• Aged 80 years or over

Exclusion Criteria:

• Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
• Severe heart and lung diseases;
• Renal insufficiency;
• Any type of tumor;
• Bedridden patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Behavioral: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System; The Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients confined to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of affected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery.
No Intervention: controlled group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of activities of daily living	Basic activities of daily living (BADL) assessed by Barthel Index	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
The change of handgrip strength	3 months

Collaborators and Investigators

• Sponsor: Yuxiang Liang

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 2020（001）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No