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Completed

NCT Number: NCT04598464

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, Balıkesir, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based exercise

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.

Primary outcomes

  1. 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

  1. Change from baseline Berg balance scale score at 3-months

    Time frame: Baseline, 3-month

    The Berg balance scale is a reliable tool for assessing balance and postural control in older adults. This scale consists of 14 items, each scored from 0 to 4, with a maximal score of 56 points. A higher score indicates better balance

  2. Change from baseline 6-minute walk test (6MWT) at 3-months

    Time frame: Baseline, 3-month

    The 6MWT is used to assess people's physical capacity. participants were asked to walk back and forth in a hospital corridor free of obstacles for 6 minutes at a regular pace.

  3. Change from baseline self-reported QoL at 3-months

    Time frame: Baseline, 3-month

    The average level of QoL was evaluated using the numeric scale and scored between 0 and 10, where 0 indicates the best QoL and 10 indicates the worst QoL

  4. Change from baseline number of falls at 3-months

    Time frame: Baseline, 3-month

    The number of falls was monitored by monthly telephone calls

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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