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

NCT07564076 | Enrolling By Invitation

• 1 other identifier: MU-FTR-OSK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frail Elderly

Keywords

Exercise Therapy; Frail Elderly; Accidental Falls; Physical Functional Performance; Postural Balance

Outcome Measures

Primary Outcomes (3)

• Mini-BESTest: Balance Evaluation Systems Test

  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'.

  two weeks

• Falls Efficacy Scale

  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.

  two weeks

• Short Physical Performance Battery (SPPB)

  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.

  two weeks

Secondary Outcomes (3)

• Fear of Falling Questionnaire Revised (FFQ-R)

  two weeks

• The Four Square Step Test (FSST)

  two weeks

• Nottingham Health Profile

  two weeks

Study Arms (3)

Vivifrail Exercise Group

EXPERIMENTAL

In this group, participants will take part in the Vivifrail Exercise Program, a 12-week multi-component exercise program. The Vivifrail Exercise Program is a personalized exercise program designed for frail older adults, incorporating various exercise types.

Other: Vivifrail Exercise Program

Otago Exercise Group

EXPERIMENTAL

Participants in this group will be enrolled in a 12-week Otago Exercise Program. Developed as a fall prevention exercise program, the Otago Exercise Program is one of the most frequently used exercise programs in geriatric individuals. It is an evidence-based exercise program whose effectiveness has been demonstrated in different geriatric populations. The Otago Exercise Program includes warm-up exercises, progressive strength and balance exercises, walking sessions, and aerobic exercise.

Other: Otago Exercise Program

Control Group

NO INTERVENTION

Participants in the control group will be evaluated at the beginning of the study and at the end of 12 weeks. They will not be included in any exercise program.

Interventions

Vivifrail Exercise Program OTHER

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.

Vivifrail Exercise Group

Otago Exercise Program OTHER

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.

Otago Exercise Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be kept unaware of which exercise program they will be enrolled in. Additionally, the statistical analysis will be performed by a researcher blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: A total of 3 groups, including one group that did not participate in the exercise program.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)