NCT05210296

Brief Summary

The aim of this study is to investigate the effect of lower extremity strengthening exercises versus trunk strengthening exercises on balance, walking, fall risk and quality of life in elderly individuals. In our study, the participants will be divided into 3 groups consisting of trunk strengthening exercises, lower extremity strengthening exercises and control groups.Body strengthening exercises and lower extremity strengthening exercises group will be included in the exercise program for a total of 40 minutes each session, 3 sessions a week, for a total of 8 weeks. The exercises will be shown and applied by the research physiotherapist in groups of 2-3 to the participants of both groups. No exercise program will be applied to the control group, and appropriate exercise training will be given after the final evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

December 25, 2021

Last Update Submit

October 31, 2022

Conditions

Keywords

ElderlyGait FunctionsBalanceStrengthening ExercisesTrunk

Outcome Measures

Primary Outcomes (3)

  • Balance Evaluation Systems Test (Mini BESTest)

    It is a test developed by using factor analysis to determine the most important elements that represent dynamic balance, and the insensitive elements other than these are eliminated. It is a reliable assessment method that provides information on which balance systems are impaired in older adults. It includes tasks in the subsections "Forward-looking", "Reactive postural control", "Sensory orientation" and "Dynamic walking" and consists of 14 items scored from 2 (normal) to 0 (severely deficient). A total of 28 points can be obtained, higher scores indicate better balance

    8 weeks

  • Activity-Specific Balance Confidence Scale

    The scale includes 16 parameters related to exterior and interior spaces in daily living activities. It assesses the perception of balance and fear of falling. Balance confidence is scored between 0-100%. It is an easy-to-apply scale that can be completed in as little as 5 minutes.

    8 weeks

  • Dynamic Gait Index

    It is a test that measures the capacity to adapt to changes during walking. It evaluates activities such as slow walking, fast walking, walking with head movements, turning, climbing stairs, jumping obstacles, 0 points weak and 3 points successful. Low scores that can be obtained from the scale are indicative of disorders that may cause falls. Evaluates a total of 8 parameters over 24 points. A score of nineteen and below defines the presence of fall risk.

    8 weeks

Secondary Outcomes (5)

  • Trunk Muscle Strength Measurement

    8 weeks

  • Lower Extremity Muscle Strength Measurement

    8 weeks

  • 10 Meter Walk Test

    8 weeks

  • Tinetti Balance and Gait Test (TBGT)

    8 weeks

  • Nottingham Health Profile (NHP)

    8 weeks

Study Arms (3)

Trunk strengthening exercises

EXPERIMENTAL

After 5 minutes of warm-up exercises, 20 minutes of trunk strengthening exercises and 10 minutes of balance exercises will be applied to the participants, and the session will end with 5 minutes of cooling-off exercises. In trunk strengthening exercises, trunk resistance exercises will be applied with an elastic exercise band.

Behavioral: Exercises

Lower extremity strengthening exercises

EXPERIMENTAL

After 5 minutes of warm-up exercises, lower extremity strengthening exercises and 10 minutes of balance exercises will be applied to the participants, and the session will end with 5 minutes of cool-down exercises. In lower extremity strengthening exercises, lower extremity resistance exercises will be applied with elastic exercise band.

Behavioral: Exercises

Control

NO INTERVENTION

Participants will not be included in any exercise program. At the end of the study, the elderly will be informed about the effects of exercises and appropriate exercise program training will be given.

Interventions

ExercisesBEHAVIORAL

Therapeutic exercise will be applied to the elderly

Lower extremity strengthening exercisesTrunk strengthening exercises

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older
  • Having adequate cognitive function ((Mini Mental State Test (MMST) score equal to or greater than 24)
  • Functional Ambulation Classification (FAC) level of 3, 4 or 5.

You may not qualify if:

  • Having cardiac diseases that prevent exercise
  • Have had any cardiac event or surgery in the last six months
  • Pulmonary embolism and deep vein thrombosis in the last three months
  • History of disabling cerebrovascular disease
  • Presence of acute retinal hemorrhage or previous ophthalmic surgery
  • Presence of active infection, malignancy or multiple organ failure
  • Terminal disease status
  • Having a history of lower and upper extremity fractures in the last three months
  • Severe hearing and vision loss
  • Being diagnosed with Parkinson's, dementia, or depression
  • Have received exercise training in the last six months
  • Multiple drug use
  • Having been diagnosed with vestibular disease
  • Existence of moderate or severe respiratory system disease that is not under control that interferes with exercise
  • Having uncontrolled hypertension
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, 77200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Physiotherapist

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 27, 2022

Study Start

June 15, 2021

Primary Completion

August 10, 2022

Study Completion

October 27, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations