Back to resultsEffect of Home-Based Exercise Program in Older Adults With Sarcopenia
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
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
Sites / Locations
- Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation
- Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
- Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
- Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
control group
Arm Description
The home-based training program
All patients participated in a one-session educational program conducted by the investigators at each clinic.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
Change from baseline number of falls at 3-months
The number of falls was monitored by monthly telephone calls
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04598464
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
The home-based training program
Arm Title
control group
Arm Type
No Intervention
Arm Description
All patients participated in a one-session educational program conducted by the investigators at each clinic.
Intervention Type
Other
Intervention Name(s)
Home based exercise
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline timed up and go test at 3-months
Description
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.
Time Frame
Baseline, 3-month
Secondary Outcome Measure Information:
Title
Change from baseline Berg balance scale score at 3-months
Description
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
Time Frame
Baseline, 3-month
Title
Change from baseline 6-minute walk test (6MWT) at 3-months
Description
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.
Time Frame
Baseline, 3-month
Title
Change from baseline self-reported QoL at 3-months
Description
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
Time Frame
Baseline, 3-month
Title
Change from baseline number of falls at 3-months
Description
The number of falls was monitored by monthly telephone calls
Time Frame
Baseline, 3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Karan, Professor
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balikesir University Faculty of Medicine, Department of Physical Therapy and Rehabilitation
City
Balıkesir
Country
Turkey
Facility Name
Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
Country
Turkey
Facility Name
Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
İzmir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34271551
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.
Results Reference
derived
Learn more about this trial
Effect of Home-Based Exercise Program in Older Adults With Sarcopenia
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