Ireland
--:--IST
Enrolling by invitation Not applicable

Comparison of the Effects of Different Exercise Protocols in Frail Elderly Individuals

NCT07564076 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-03-10
Last updated
2026-05-04

Condition(s) studied

Frail Elderly

Investigational drug(s) / intervention(s)

Vivifrail Exercise ProgramOtago Exercise Program

Vivifrail Exercise Program: Following an initial assessment and random assignment to exercise groups, participants will undergo a multicomponent exercise program (Vivifrail) consisting of 60 sessions, 5 days a week, for 12 weeks. Each session will last approximately 60 minutes and will be conducted on two non-consecutive days with a physiotherapist present, and on the other three days following instructions given by the physiotherapist and patient education. The program will be supervised by the institution's physician, who is also a researcher in the study, and will include an organization that can provide emergency assistance if needed. Participants will be provided with the necessary equipment for the exercises (resistance bands, towels, and water bottles). Attendance at exercise sessions will be recorded.

Otago Exercise Program: The Otago Exercise Program (OEP) consists of balance and strengthening exercises and walking exercises. Each exercise session in the OEP begins with 5-7 minutes of light warm-up exercises and continues with approximately 30-35 minutes of strengthening and balance exercises. Additionally, participants are included in moderate-paced walking sessions for 30 minutes at least twice a week on days when the exercise program is not in progress. The number of repetitions, frequency, intensity, and duration of the exercises are planned individually for each participant. In our study, balance and strengthening exercises will be performed twice a week in a group setting with a physiotherapist. Each group will consist of 4-5 participants with similar physical capacity and function.

Study summary

The aim of this research is to investigate and compare the effects of two different exercise programs developed for frail geriatric individuals on fall risk, fear of falling, and physical performance.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Volunteering to participate in the study * Having been diagnosed as frail according to Fried Frail Phenotype (3 or more criteria) * Being able to walk with or without a walking aid Exclusion Criteria: * Being in the terminal stage of illness * Presence of cognitive impairment (Mini Mental State Assessment score below 24) * Severe vision and hearing loss * Acute myocardial infarction (within the last 3-6 months) or unstable angina; * Uncontrolled atrial or ventricular arrhythmias; * Aortic dissection aneurysm; * Severe aortic stenosis; * Acute endocarditis/pericarditis; * Uncontrolled high blood pressure (\> 180/100 mmHg); * Acute thromboembolism; * Acute or severe heart failure; * Acute or severe respiratory failure; * Uncontrolled postural hypotension; * Uncontrolled acute decompensated diabetes or low blood sugar; * History of fracture within the last 3 months

Primary outcome measure(s)

  • Mini-BESTest: Balance Evaluation Systems Test — two weeks
    Developed by Franchignoni et al. in 2010, the Mini-BESTest consists of four groups: pre-postural preparation, reactive postural responses, sensory orientation, and gait balance. The test contains 14 items, each scored between 0 and 2. '0' represents the lowest functional level, and '2' represents the highest. The lowest possible score on the Mini-BESTest is '0', and the highest is '28'.
  • Falls Efficacy Scale — two weeks
    This scale, developed by Yardley et al. in 2005, assesses fear of falling. The FFS consists of 16 items, each scored from 1 to 4. The total score ranges from 16 to 24, with a higher score indicating greater fear of falling.
  • Short Physical Performance Battery (SPPB) — two weeks
    Guralnik et al. developed this test by combining balance, timed up and go, and walking speed tests. The first test assesses static balance in three standing positions, the second test assesses lower extremity strength and power after standing and sitting in a chair, and the third test assesses walking speed at a normal pace. Each test is scored from 0 (failure to perform the task) to 4 points (best test performance). The total score is between 0 and 12. A high score is considered good performance.

Trial sites (1)

FacilityCityRegionStatus
Marmara University Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07564076 on ClinicalTrials.gov ↗ ← All trials in Turkey