- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355299
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
Status
Completed
Conditions
Intervention / Treatment
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:
- aged ≥80 years;
- being able to ambulate (assistance was acceptable);
- being able to communicate and collaborate with the physiotherapist;
- with sarcopenia defined by the AWGS criteria ;
Exclusion Criteria:
- terminal illness;
- uncontrolled heart failure;
- myocardial infarction within the past three months;
- uncontrolled respiratory failure;
- bone fractures within the past three months;
- acute pulmonary embolism;
- major surgery within the past three months;
- uncontrolled arrhythmia;
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019#611#
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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