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

• Sponsor: Yuxiang Liang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04497480
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Behavioral: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
• Actual Study Start Date: Jul 28, 2020
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of activities of daily living [3 Months]

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

Secondary Outcome Measures

1. The change of handgrip strength [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 80 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital，Sichuan University	Chengdu	Sichuan	China	610064

Sponsors and Collaborators

• Yuxiang Liang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuxiang Liang, Physiotherapist, West China Hospital
• ClinicalTrials.gov Identifier: NCT04497480
• Other Study ID Numbers: 2020（001）
• First Posted: Aug 4, 2020
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia

Study Results

No Results Posted as of Sep 14, 2021