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

NCT04497480 | Unknown

• 1 other identifier: 2020（001）
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The change of activities of daily living

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

  3 Months

Secondary Outcomes (1)

• The change of handgrip strength

  3 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

controlled group

NO INTERVENTION

Interventions

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

experimental group

Eligibility Criteria

• Age: 80 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuxiang Liang: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, 610064, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: July 28, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CN (1)