Clinical trial NCT04598464: Effect of Home-Based Exercise Program in Older Adults With Sarcopenia
Official title: Effect of Home-Based Exercise Program on Physical Function and Balance in Older Adults With Sarcopenia: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline timed up and go test at 3-months
timeFrame: Baseline, 3-month
Secondary outcomes:
measure: Change from baseline Berg balance scale score at 3-months
timeFrame: Baseline, 3-month
measure: Change from baseline 6-minute walk test (6MWT) at 3-months
timeFrame: Baseline, 3-month
measure: Change from baseline self-reported QoL at 3-months
timeFrame: Baseline, 3-month
measure: Change from baseline number of falls at 3-months
timeFrame: Baseline, 3-month
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation
city: Istanbul
country: Turkey
facility: Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Ayse Karan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.