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Clinical Trials/NCT04598464
NCT04598464
Completed
Not Applicable

Effect of Home-Based Exercise Program on Physical Function and Balance in Older Adults With Sarcopenia: A Multicenter Randomized Controlled Study

Istanbul University5 sites in 1 country100 target enrollmentMarch 1, 2018
ConditionsSarcopenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Istanbul University
Enrollment
100
Locations
5
Primary Endpoint
Change from baseline timed up and go test at 3-months
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

In the prospective, randomized, controlled multi-centre study, 100 patients who were clinically diagnosed with sarcopenia were assigned to either a home-based exercise group or the control group. The home-based exercise program was performed three days per week for 12 weeks. Before and three months after the exercise program, all the patients were evaluated.

Detailed Description

Sarcopenia is a complex and multifactorial syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength.The randomized, multicenter study was conducted at the physical medicine and rehabilitation departments of five different centers. One hundred patients met the inclusion and exclusion criteria and were randomly allocated to either a home-based exercise group (n=50) or a control group (n=50). The patients were evaluated before and 3 months after inclusion using the timed up and go test, the Berg balance scale, the 6-minute walk test , a numeric rating scale to determine QoL, and the number of falls.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ekin Ilke Sen

Assistant Professor

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • community-dwelling older adult diagnosis of sarcopenia according to the clinical examination; and able to walk independently. The physical performance of patients with a SARC-F score ≥4 were tested using a gait speed test and a short physical performance battery (SPPB). The diagnosis of sarcopenia was confirmed in cases where the patient's gait speed was ≤0.8 m/s and the SPPB score was ≤8

Exclusion Criteria

  • having cardiovascular, pulmonary, and/or chronic diseases that may affect participation in the exercise program; impaired cognition; previous diagnosis of a neurological condition that severely affected mobility and balance; malignancy; metastatic cancer; serious vision loss or vestibular impairment

Outcomes

Primary Outcomes

Change from baseline timed up and go test at 3-months

Time Frame: Baseline, 3-month

The timed up and go test test measures the amount of time needed for a patient to stand up from a chair, walk three meters as quickly and safely as possible toward a cone, walk around it, and sit down on the chair again.

Secondary Outcomes

  • Change from baseline 6-minute walk test (6MWT) at 3-months(Baseline, 3-month)
  • Change from baseline Berg balance scale score at 3-months(Baseline, 3-month)
  • Change from baseline self-reported QoL at 3-months(Baseline, 3-month)
  • Change from baseline number of falls at 3-months(Baseline, 3-month)

Study Sites (5)

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