ElderlyNCT05210296
The Effect of Lower Extremity Strengthening Exercises Versus Trunk Strengthening Exercises
A study testing Exercises in people with Elderly and Balance, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Having diabetes with diabetes complications such as nephropathy, retinopathy and severe neuropathy, or uncontrolled diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lower Extremity Strengthening Exercises Versus Trunk Strengthening Exercises on Balance and Gait Functions in Elderly Individuals
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.
Read the detailed description
Those aged 65 and over, residing in Yalova and agreeing to be included in the study, will be included in the study. Volunteers who will participate in the study will be informed about the purpose of the study, its duration, and possible side effects of the treatment to be applied. Their consent will be obtained with an "Informed Consent Form" prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul University Cerrahpaşa Faculty of Medicine, and the study will be carried out in accordance with the Declaration of Helsinki. 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.
Evaluation scales will be administered to the participants at the beginning of the study and 8 weeks later.
Body weight, own weight of the extremity and elastic exercise band will be used in strengthening exercises in trunk strengthening exercises and lower extremity strengthening exercises groups.
The weight of the extremity itself, or the number of repetitions in exercises using body weight, will be determined at the initial assessment according to the patient's exercise tolerance for each exercise. For each exercise, the exercise program will be started with the number of repetitions perceived by the participant according to the Modified Borg Scale (MBS), the number of repetitions will be increased, the program will be continued with the number of repetitions, the perceived fatigue severity will be between 4-7, by increasing the number of repetitions weekly. will be.
Appropriate band selection for the exercises to be used with an elastic exercise band will be determined according to the participant's tolerance and muscle strength. Participants will be asked to do the exercise for 15 repetitions with the lowest level of exercise band first, and then the perceived fatigue severity will be questioned by MBS. If the exercise intensity perceived by the participant is between 4 and 7, it will be determined as the correct band. If the participant's perceived severity is lower, the process with the next higher band will be repeated until the correct band is found for the patient. The same process will be applied for the tape to be used in the strengthening training of each region.
Elastic band exercises will be started with 8 repetitions, and the intensity of exercise will be questioned by increasing the number of repetitions by 2 in the first exercise session each week. If the perception of exercise intensity has increased, the number of repetitions will be kept the same, if the exercise intensity does not increase, the number of repetitions will be continued as 10, the next week after the exercise as 12 repetitions, the color of the exercise band will be changed and the exercise intensity will be evaluated by switching to the next band, and if the exercise intensity is appropriate, the previous band will be evaluated.
- Being tested
- Exercises
- Keywords
- Elderly, Gait Functions, Balance, Strengthening Exercises, Trunk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesBehavioural
Therapeutic exercise will be applied to the elderly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (5)
Trunk Muscle Strength Measurement
For the measurement, they are asked to push the handheld dynamometer held steady for five seconds with all their strength. Trunk flexor, extensor, right and left lateral flexor, right and left rotator muscle strength will be evaluated. The measurement score will be taken as the highest value test score out of three measurements made two minutes apart.
Measured: 8 weeks
Lower Extremity Muscle Strength Measurement
For the measurement, they are asked to push the handheld dynamometer held steady for five seconds with all their strength. Muscle strength of lower extremity hip flexor-extensor-abductors, knee flexors and extensors, ankle dorsi and plantar flexors will be evaluated. The measurement score will be taken as the highest value test score out of three measurements made two minutes apart.
Measured: 8 weeks
10 Meter Walk Test
In this test, the person is asked to walk at their own normal pace in a pre-measured 10 meter area (if using walking aid, it will be carried out with it). The time starts when the person's foot is on the starting line and ends when he crosses the finish line. Two measurements are made and the best value is recorded in meters/second (m/s).
Measured: 8 weeks
Tinetti Balance and Gait Test (TBGT)
TBGT, which is preferred especially in determining the risk of falling in the elderly, was first developed by Mary Tinetti under the name Performance-Oriented Assessment of Mobility Problems in Elderly Patients to evaluate patients at high risk of falling. It was later developed and named Tinetti Gait and Balance Assessment. TBGT evaluates balance ability and gait under 2 main headings: The first 9 items are about balance and the next 7 items are about walking. The total score of the first 9 items gives the balance score, and the total score of the next 7 items gives the walking score. If the total score of the scale is 18 and below, the risk of falling is high, if it is 19-24, the risk of falling is moderate, and a score of 25 and above indicates a low risk of falling.
Measured: 8 weeks
Nottingham Health Profile (NHP)
NHP is a measure of general health status that measures individuals' perceived distress in physical, emotional and social areas. It consists of a total of 38 items: physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Each item is answered as "yes" or "no". It is one of the advantages of the scale that it includes sleep and pain sub-headings, and it allows a versatile assessment of the individual's point of view on health.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Jun 2021
- Primary completion10 Aug 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri Köroğlu, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210296
- Sponsor's protocol ID
- YALOVAÜNİVERSİTESİ-FAHRİ.K-077
- Status last verified
- Oct 2022
- First submitted
- 25 Dec 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Extremity Strengthening Exercises Versus Trunk Strengthening Exercises on Balance and Gait Functions in Elderly Individuals
- ClinicalTrials.gov ID
- NCT05210296
- Acronym / sponsor ID
- YALOVAÜNİVERSİTESİ-FAHRİ.K-077
- Keywords
- Elderly, Gait Functions, Balance, Strengthening Exercises, Trunk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Those aged 65 and over, residing in Yalova and agreeing to be included in the study, will be included in the study. Volunteers who will participate in the study will be informed about the purpose of the study, its duration, and possible side effects of the treatment to be applied. Their consent will be obtained with an "Informed Consent Form" prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul University Cerrahpaşa Faculty of Medicine, and the study will be carried out in accordance with the Declaration of Helsinki. 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.
Evaluation scales will be administered to the participants at the beginning of the study and 8 weeks later.
Body weight, own weight of the extremity and elastic exercise band will be used in strengthening exercises in trunk strengthening exercises and lower extremity strengthening exercises groups.
The weight of the extremity itself, or the number of repetitions in exercises using body weight, will be determined at the initial assessment according to the patient's exercise tolerance for each exercise. For each exercise, the exercise program will be started with the number of repetitions perceived by the participant according to the Modified Borg Scale (MBS), the number of repetitions will be increased, the program will be continued with the number of repetitions, the perceived fatigue severity will be between 4-7, by increasing the number of repetitions weekly. will be.
Appropriate band selection for the exercises to be used with an elastic exercise band will be determined according to the participant's tolerance and muscle strength. Participants will be asked to do the exercise for 15 repetitions with the lowest level of exercise band first, and then the perceived fatigue severity will be questioned by MBS. If the exercise intensity perceived by the participant is between 4 and 7, it will be determined as the correct band. If the participant's perceived severity is lower, the process with the next higher band will be repeated until the correct band is found for the patient. The same process will be applied for the tape to be used in the strengthening training of each region.
Elastic band exercises will be started with 8 repetitions, and the intensity of exercise will be questioned by increasing the number of repetitions by 2 in the first exercise session each week. If the perception of exercise intensity has increased, the number of repetitions will be kept the same, if the exercise intensity does not increase, the number of repetitions will be continued as 10, the next week after the exercise as 12 repetitions, the color of the exercise band will be changed and the exercise intensity will be evaluated by switching to the next band, and if the exercise intensity is appropriate, the previous band will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Trunk strengthening exercises | Experimental | Behavioral: ExercisesAfter 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. |
| Lower extremity strengthening exercises | Experimental | Behavioral: ExercisesAfter 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesTherapeutic exercise will be applied to the elderly | Behavioural | Lower extremity strengthening exercises, Trunk strengthening exercises |
Primary outcome
Balance Evaluation Systems Test (Mini BESTest)
Time frame: 8 weeks
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
Activity-Specific Balance Confidence Scale
Time frame: 8 weeks
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.
Dynamic Gait Index
Time frame: 8 weeks
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.
5 secondary outcomes
Trunk Muscle Strength Measurement
Time frame: 8 weeks
Lower Extremity Muscle Strength Measurement
Time frame: 8 weeks
10 Meter Walk Test
Time frame: 8 weeks
Tinetti Balance and Gait Test (TBGT)
Time frame: 8 weeks
Nottingham Health Profile (NHP)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Elderly and Balance, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Evaluation Systems Test (Mini BESTest) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.