NCT04598464

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

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

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

October 16, 2020

Last Update Submit

October 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline, 3-month

Secondary Outcomes (4)

  • Change from baseline Berg balance scale score at 3-months

    Baseline, 3-month

  • Change from baseline 6-minute walk test (6MWT) 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 Arms (2)

Exercise group

EXPERIMENTAL

The home-based training program

Other: Home based exercise

control group

NO INTERVENTION

All patients participated in a one-session educational program conducted by the investigators at each clinic.

Interventions

The home-based training program included posture and stretching exercises, strengthening exercises, balance training, and a walking regimen 3 days per week for 3 months.

Exercise group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation

Balıkesir, Turkey (Türkiye)

Location

Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • Sen EI, Eyigor S, Dikici Yagli M, Ozcete ZA, Aydin T, Kesiktas FN, Aydin FY, Vural M, Sahin N, Karan A. Effect of Home-Based Exercise Program on Physical Function and Balance in Older Adults With Sarcopenia: A Multicenter Randomized Controlled Study. J Aging Phys Act. 2021 Jul 16;29(6):1010-1017. doi: 10.1123/japa.2020-0348.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ayse Karan, Professor

    Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

March 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations