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

NCT ID: NCT04497480

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-12-01

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

experimental group

Group Type: EXPERIMENTAL

Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System

Intervention Type: BEHAVIORAL

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.

controlled group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 80 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuxiang Liang

OTHER

Sponsor Role: lead

Responsible Party

Yuxiang Liang

Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuxiang Liang

Role: primary

yx45liang@sina.com

0086-13982250862

Other Identifiers

2020（001）

Identifier Type: -

Identifier Source: org_study_id