NCT04355299

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

April 17, 2020

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change of activities of daily living from the baseline to the end of the 2-week intervention

    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 Outcomes (4)

  • The change of gait speed

    2 weeks

  • The change of handgrip strength

    2 weeks

  • The change of the score of Short Physical Performance Battery

    2 weeks

  • The change of the score of Timed Up and Go test

    2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.

Behavioral: balance trainingBehavioral: resistance trainingBehavioral: aerobic exercise

control group

OTHER

usual care

Behavioral: usual care

Interventions

The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.

Intervention group

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.

Intervention group

Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.

Intervention group
usual careBEHAVIORAL

received usual care

control group

Eligibility Criteria

Age80 Years - 102 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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 ;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jiaojiao Jiang

    West China Hospital

    PRINCIPAL INVESTIGATOR
  • Ming Yang

    West China Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

October 1, 2016

Primary Completion

December 30, 2019

Study Completion

January 1, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04