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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598464
• Other study ID #: IstanbulU-2018-200
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: October 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation	Balikesir
Turkey	Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital	Istanbul
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul
Turkey	Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul
Turkey	Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline Berg balance scale score at 3-months	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	Baseline, 3-month
Secondary	Change from baseline 6-minute walk test (6MWT) at 3-months	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.	Baseline, 3-month
Secondary	Change from baseline self-reported QoL at 3-months	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	Baseline, 3-month
Secondary	Change from baseline number of falls at 3-months	The number of falls was monitored by monthly telephone calls	Baseline, 3-month