Effect of Home-Based Exercise Program in Older Adults With Sarcopenia

NCT ID: NCT04598464

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise group

The home-based training program

Group Type EXPERIMENTAL

Home based exercise

Intervention Type OTHER

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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home based exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Ekin Ilke Sen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Karan, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Balıkesir, , Turkey (Türkiye)

Site Status

Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

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

Istanbul, , Turkey (Türkiye)

Site Status

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

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34271551 (View on PubMed)

Other Identifiers

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IstanbulU-2018-200

Identifier Type: -

Identifier Source: org_study_id

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