Aging WellNCT06040554
The Effect Of A Resistance Exercise Program On Balance Of Elderly People
A study testing Elastic Band Resistance Exercises in people with Aging Well and Aging, run by University of West Attica at 1 site in Greece.
Trial summary
The purpose of the present study is to investigate the effectiveness of a resistance exercise program consisting of elastic band exercises to balance, strength and quality of life of community-dwelling elders. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Aging
- What is being tested?
- Elastic Band Resistance Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 20 Sep 2023to 1 Dec 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years old
- Able to consent to participation
- Able to stand without assistive devices
- Able to participate in strength training
- Able to perform activities of Daily Living independently
- Cognitively and psychologically able to participate in a group setting
Who cannot join
- Systematically exercised for up to 6 months prior to start of study
- Neurological disorders or inability to stand
- Recent surgery or contraindications to exercise
- Arthroplasty or Prosthetic Limbs
- Vision or Hearing problems hindering participation in group
- Medication or Disorders contraindicating exercise or standing
- Hypotension or Orthostatic Hypotension
- Malignancy or Recent Treatment for Malignancy
Trial locations and contacts
1 site in 1 country.
N Chrisagis, Phd contact
About this study
Official title: The Effect Of A Resistance Exercise Program On Balance Of Elderly People: A Pilot Trial
The purpose of the present study is to investigate the effectiveness of a resistance exercise program consisting of elastic band exercises to balance, strength and quality of life of community-dwelling elders. The hypothesis of the study is that the people training with elastic bands will show benefits on the aforementioned areas.
Read the detailed description
The elderly are, according to research, prone to an accelerated rate of loss of balance, particularly after the age of 60. This loss of balance could translate to injurious falls which could lead to trauma, fear of falling or even hospitalization. It has been shown in multiple studies that strength training can provide health benefits to the general population improving strength, balance, postural control, bone health and quality of life.
Elastic band exercises could be applied to a number of different settings due to the comparably low cost of equipment and due to the easiness of handling the equipment. In previous studies, elastic band exercise programs, varied in design, have been shown to provide multiple benefits to elderly people. In this study, it is proposed that in a Community Center for Elderly People, which are widely established in Greece, a group of eligible community dwelling elderly could exercise under supervision using elastic bands in a group setting.
The recruitment will take place in a Community Center for Elders. A group of people aged over 65, able and cleared to participate in strength training will participate. Information sheet and consent form will be provided to all participants. A pilot randomized intervention study is designed to assess the efficacy of elastic band resistance training as means to improve balance, strength and quality of life where the sample will be randomized to one of two following study groups:
- exercise program group (intervention group)
- no change of activities of daily living (control group)
Assessment will be obtained in two-time periods: prior to the program and after the program.
The exercise program will take place twice-weekly for eight weeks.
Participants will be assessed using Berg Balance Scale, Gait Speed, Timed Up and Go, 30 Seconds Chair Stand Test, Handgrip Strength, Knee Extensors and Flexors Strength, Fall Efficacy Scale.
- Conditions
- Aging Well, Aging
- Being tested
- Elastic Band Resistance Exercises
- Keywords
- aging, elderly, strength, balance, elastic band
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Band Resistance ExercisesOther
8 Warm-Up Exercises followed by 10 Elastic Band Exercises followed by 8 Post-Workout Exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | Participants will participate in a group resistance exercise program for 8 weeks, using elastic bands. Receives: Other: Elastic Band Resistance Exercises |
| Unchanged Activities of Daily Living | No intervention | Participants will be asked not to change their activities of daily living for the duration of the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
Secondary outcomes (6)
Gait Speed 4 Meters
The speed with which a patient walks for 4 meters. Gait speed is a metric that is extremely valuable for practitioners when examining aspects of functional mobility in their patients. Additionally, given its ability to be influenced by multiple body systems (i.e. central nervous system, musculoskeletal system), gait speed is often used as a predictor of overall health and function, especially in older adults.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
Timed Up and Go
The patient is asked to stand from a sitting position, walk for three meters, turn around and return to seat. The purpose of this is to determine fall risk and measure the progress of balance, sit to stand and walking. It is a simple screening test that is a sensitive and specific measure of probability for falls among older adults.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
30 Seconds Chair Stand Test
Patient is asked to alternate between sitting and standing for 30 seconds. The 30 second chair stand test is for testing leg strength and endurance in older adults.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
Handgrip Strength
Grip Strength is measured by use of a Grip Dynamometer. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.
Measured: Prior to the 1st week of the training program, After the end of the 8th week of the training program
Lower Limb Strength (Flexors - Extensors of Knee)
Muscle Strength will be measured by use of Dynamometer. An assessment of muscle strength is typically performed as part of a patient's objective assessment and is an important component of the physical exam that can reveal information about neurologic deficits. It is used to evaluate weakness and can be effective in differentiating true weakness from imbalance or poor endurance.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
Fall Efficacy Scale International (FES-I)
The Falls Efficacy Scale International (FES-I) is a measure of "fear of falling" or "concerns about falling", developed as a part of the Prevention of Falls Network Europe (ProFaNE) project from 2003 to 2006 by Todd et al. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). The FES-I is intended to be used in adult population to measure the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
Measured: At baseline and after the end of the 8th week of the training program, at week number 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start20 Sep 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kontonikas Konstantinos, University of West Attica
- Investigators
- K Kontonikas, Principal investigator, University West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040554
- Sponsor's protocol ID
- UWestAttica
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of A Resistance Exercise Program On Balance Of Elderly People: A Pilot Trial
- ClinicalTrials.gov ID
- NCT06040554
- Acronym / sponsor ID
- UWestAttica
- Conditions
- Aging Well, Aging
- Keywords
- aging, elderly, strength, balance, elastic band
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Sep 2023 (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 purpose of the present study is to investigate the effectiveness of a resistance exercise program consisting of elastic band exercises to balance, strength and quality of life of community-dwelling elders. The hypothesis of the study is that the people training with elastic bands will show benefits on the aforementioned areas.
Detailed description
The elderly are, according to research, prone to an accelerated rate of loss of balance, particularly after the age of 60. This loss of balance could translate to injurious falls which could lead to trauma, fear of falling or even hospitalization. It has been shown in multiple studies that strength training can provide health benefits to the general population improving strength, balance, postural control, bone health and quality of life.
Elastic band exercises could be applied to a number of different settings due to the comparably low cost of equipment and due to the easiness of handling the equipment. In previous studies, elastic band exercise programs, varied in design, have been shown to provide multiple benefits to elderly people. In this study, it is proposed that in a Community Center for Elderly People, which are widely established in Greece, a group of eligible community dwelling elderly could exercise under supervision using elastic bands in a group setting.
The recruitment will take place in a Community Center for Elders. A group of people aged over 65, able and cleared to participate in strength training will participate. Information sheet and consent form will be provided to all participants. A pilot randomized intervention study is designed to assess the efficacy of elastic band resistance training as means to improve balance, strength and quality of life where the sample will be randomized to one of two following study groups:
- exercise program group (intervention group)
- no change of activities of daily living (control group)
Assessment will be obtained in two-time periods: prior to the program and after the program.
The exercise program will take place twice-weekly for eight weeks.
Participants will be assessed using Berg Balance Scale, Gait Speed, Timed Up and Go, 30 Seconds Chair Stand Test, Handgrip Strength, Knee Extensors and Flexors Strength, Fall Efficacy Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Other: Elastic Band Resistance ExercisesParticipants will participate in a group resistance exercise program for 8 weeks, using elastic bands. |
| Unchanged Activities of Daily Living | No intervention | –Participants will be asked not to change their activities of daily living for the duration of the research. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Over 65 years old
- Able to consent to participation
- Able to stand without assistive devices
- Able to participate in strength training
- Able to perform activities of Daily Living independently
Key exclusion criteria (8 listed)
- Systematically exercised for up to 6 months prior to start of study
- Neurological disorders or inability to stand
- Recent surgery or contraindications to exercise
- Arthroplasty or Prosthetic Limbs
- Vision or Hearing problems hindering participation in group
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 |
|---|---|---|
| Elastic Band Resistance Exercises8 Warm-Up Exercises followed by 10 Elastic Band Exercises followed by 8 Post-Workout Exercises. | Other | Exercise Program |
Primary outcome
Berg Balance Scale
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
6 secondary outcomes
Gait Speed 4 Meters
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
Timed Up and Go
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
30 Seconds Chair Stand Test
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
Handgrip Strength
Time frame: Prior to the 1st week of the training program, After the end of the 8th week of the training program
Lower Limb Strength (Flexors - Extensors of Knee)
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
Fall Efficacy Scale International (FES-I)
Time frame: At baseline and after the end of the 8th week of the training program, at week number 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
N Chrisagis, Phd contact
K Kontonikas principal investigator
University West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band Resistance Exercises in people with Aging Well and Aging, run by University of West Attica at 1 site in Greece.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact K Kontonikas (694062554, mscphys21004@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: At baseline and after the end of the 8th week of the training program, at week number 9). 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 15 Sep 2023.