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

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System
Sponsored by
Yuxiang Liang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

80 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West China Hospital，Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

controlled group

Arm Description

Outcomes

Primary Outcome Measures

The change of activities of daily living
Basic activities of daily living (BADL) assessed by Barthel Index

Secondary Outcome Measures

The change of handgrip strength

Full Information

First Posted
July 29, 2020
Last Updated
September 13, 2021
Sponsor
Yuxiang Liang
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1. Study Identification

Unique Protocol Identification Number
NCT04497480
Brief Title
The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years
Official Title
Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuxiang Liang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Title
controlled group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of activities of daily living
Description
Basic activities of daily living (BADL) assessed by Barthel Index
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
The change of handgrip strength
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610064
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiang Liang
Phone
0086-13982250862
Email
yx45liang@sina.com

12. IPD Sharing Statement

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

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