A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years

April 20, 2020 updated by: Yuxiang Liang

Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older

Most previous clinical trials that addressed exercise 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 exercise 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 exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.

Study Overview

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years to 102 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. aged ≥80 years;
  2. being able to ambulate (assistance was acceptable);
  3. being able to communicate and collaborate with the physiotherapist;
  4. with sarcopenia defined by the AWGS criteria ;

Exclusion Criteria:

  1. terminal illness;
  2. uncontrolled heart failure;
  3. myocardial infarction within the past three months;
  4. uncontrolled respiratory failure;
  5. bone fractures within the past three months;
  6. acute pulmonary embolism;
  7. major surgery within the past three months;
  8. uncontrolled arrhythmia;
  9. refusal to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.
The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.
Other: control group
usual care
received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of activities of daily living from the baseline to the end of the 2-week intervention
Time Frame: 2 weeks
Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of gait speed
Time Frame: 2 weeks
Gait speed was measured using a 4-meter walking test.
2 weeks
The change of handgrip strength
Time Frame: 2 weeks
Handgrip strength was measured using a digital grip dynamometer
2 weeks
The change of the score of Short Physical Performance Battery
Time Frame: 2 weeks
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
2 weeks
The change of the score of Timed Up and Go test
Time Frame: 2 weeks
The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ming Yang, West China Hospital
  • Principal Investigator: Jiaojiao Jiang, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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