StabilityNCT05224362
Acute Effects of Elastic Band Resistance on Postural Stability and Physical Function in Older Adults
A study testing A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. in people with Stability and Posturography, run by University of Derby at 2 sites in United Kingdom.
Trial summary
Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stability, Posturography, Balance
- What is being tested?
- A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Apr 2022to 27 Jul 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
- Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
- Ability to walk without a walking aid
- Ability to provide consent. This will be determined by using the Mini Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired
Who cannot join
- Individuals that are under the age of 50 years old
- Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
- Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are not physically active (METs score under 600 MET-min/ week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Derby
Derby, de22 11gb
University Of Derby
Derby, DE22 1GB
About this study
Official title: Acute Effects of Elastic Band Resistance Applied to the Hip and Chest Region on Postural Stability and Physical Function Before, Immediately and up to 30 Min After Exercise in Physically Active Older Adults
Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions. The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Static posturography will assess the impacts of the exercise intervention on balance and stability.
Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults.
The study will establish the physical impact and practicalities of a novel elastic band resistance exercise intervention in older adults by performing force plate posturography and researcher led interviews that will focus on the participants perceptions of the activities and intensity levels to co-create an intervention that is accessible, acceptable, and appropriate for older adults.
Read the detailed description
Outline of study designThe following study will be a repeated measures design. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will not be recruited through HSN facilities or via any NHS platform. Participants will be required to attend three separate sessions with at least 48-72hours in between each session. Each session will be randomized in order to mitigate any bias and allow comparability of the 3 conditions. Experimental session one: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the hip region. Experimental session two: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the chest region. Experimental session three (control group): Participants will be required to perform pre-selected exercises without an elastic resistance band. The exercise intensity is measured throughout by RPE before, during and after each exercise.
intensity. Participants will be asked to simply perform the exercises not at any specific intensity. Force plate posturography measurements will be recorded before and immediately after and 30 minutes after the exercise intervention. The other quantitative measures (heart rate, rate of perceived exertion) will be recorded throughout the intervention and one-to-one interviews using a semi structured interview guide will be performed at the end of each session. The session order will be randomized for each participant to counterbalance the outcome which emerge from the study.
Participant preparation will include a detailed invitation to attend and briefing using a pre-prepared participant information sheet. Participants will be required to complete and return an International physical activity questionnaire, Falls efficacy scale, Confidence in maintaining balance and Instrumental Activities of Daily Living form.
Upon arrival of each session participants will be required to read and sign an informed consent form, a general health screen questionnaire and mini mental state examination. Participants will be required to complete all 3 sessions which will be supervised in the Kirtley building laboratory at the University of Derby (3 x experimental trial). Instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation.
- Conditions
- Stability, Posturography, Balance, Old Age; Debility
- Being tested
- A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.Device
Also called Elastic Resistance Band Training, Balance training in Older Adults, Stability Training using Resistance bands in Older Adults, The acute effects of using Elastic Resistance Bands in Older Adults
A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. Bertec force plate analysis will be performed to assess the acute effects on balance and stability. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
| Study group | Role | What they receive |
|---|---|---|
| Hip Region | Experimental | Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the hip region.
Warm up: 5-10 mins
Exercises:
Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule Receives: Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. |
| Chest Region | Experimental | Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest).
Warm up: 5-10 mins
Exercises:
Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule Receives: Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. |
| No elastic band | Placebo comparator | Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant.
Warm up: 5-10 mins
Exercises:
Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule Receives: Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bertec Force plate posturography
Centre of pressure displacement and velocity parameters will be measured using a Bertec force plate and Pro-Vec software. Measurements include the position traces of anterior-posterior and mediolateral centre of pressure to provide feedback of postural stability. In particular, the mean displacement, root-mean-squared distance from mean, root-mean-square-velocity and the mean velocity of centre of pressure. Participants will stand upright and relaxed in the centre of a portable Bertec force plate with hands on hips and feet touching each other.
Data will be collected under 4 different conditions: normal standing with eyes open, normal standing with eyes closed, a tandem stance with eyes open and a tandem stance with eyes closed. This will enable the proprioception and vestibular system to be assessed. Postural sway will be measured in the anteroposterior and mediolateral directions.
Measured: through study completion, an average of 1 year
Semi structured Interview
A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol. Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement. This will help to build insights into the participant preferences which is an important element of the intervention design.
Measured: through study completion, an average of 1 year
Heart rate
Heart rate measures will be taken during each exercise. Higher values = higher exertion of each exercise performed. 50 beats per min - 120 = low, 120- 150 beats per min = moderate and 150 beats per min = high.
Measured: through study completion, an average of 1 year
Rate of perceived exertion (RPE)
RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion exhaustion.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Mini Balance Evaluation Test (MINI-BESTest)
This assessment will require participants to perform a series of physical performance tasks. Following each task, the researcher will record the scores to sum a total score for the MINI BESTest. Scoring: The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" = lowest level of function and "2" = highest level of function.
If a subject must use an assistive device for an item, score that item one category lower.
If a subject requires physical assistance to perform an item, score "0" for that item.
Measured: through study completeion, an average of 1 year
Short Falls efficacy scale (FES 1)
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities. The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item. A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).
Measured: through study completion, an average of 1 year
Balance Confidence Questionnaire (CONFbal)
This questionnaire contains 10 scale items which will be summed to give an index of balance confidence.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start6 Apr 2022
- Primary completion1 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StabilityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Derby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nichola Davis, University of Derby
- Investigators
- Andy Pringle, Study director, University of Derby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224362
- Sponsor's protocol ID
- NDavis
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
PubMed 15304540Carroll TJ, Barry B, Riek S, Carson RG. Resistance training enhances the stability of sensorimotor coordination. Proc Biol Sci. 2001 Feb 7;268(1464):221-7. doi: 10.1098/rspb.2000.1356.
PubMed 11217890Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.
PubMed 20703977Colado JC, Triplett NT. Effects of a short-term resistance program using elastic bands versus weight machines for sedentary middle-aged women. J Strength Cond Res. 2008 Sep;22(5):1441-8. doi: 10.1519/JSC.0b013e31817ae67a.
PubMed 18714245Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.
PubMed 11322678Gerards MHG, McCrum C, Mansfield A, Meijer K. Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice. Geriatr Gerontol Int. 2017 Dec;17(12):2294-2303. doi: 10.1111/ggi.13082. Epub 2017 Jun 16.
PubMed 28621015Lima FF, Camillo CA, Gobbo LA, Trevisan IB, Nascimento WBBM, Silva BSA, Lima MCS, Ramos D, Ramos EMC. Resistance Training using Low Cost Elastic Tubing is Equally Effective to Conventional Weight Machines in Middle-Aged to Older Healthy Adults: A Quasi-Randomized Controlled Clinical Trial. J Sports Sci Med. 2018 Mar 1;17(1):153-160. eCollection 2018 Mar.
PubMed 29535589Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
PubMed 26048054Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
PubMed 17540020Youdas JW, Adams KE, Bertucci JE, Brooks KJ, Nelson MM, Hollman JH. Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance. J Sport Rehabil. 2014 Feb;23(1):1-11. doi: 10.1123/jsr.2012-0082. Epub 2013 Aug 6.
PubMed 23921445
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Elastic Band Resistance Applied to the Hip and Chest Region on Postural Stability and Physical Function Before, Immediately and up to 30 Min After Exercise in Physically Active Older Adults
- ClinicalTrials.gov ID
- NCT05224362
- Acronym / sponsor ID
- NDavis
- Conditions
- Stability, Posturography, Balance, Old Age; Debility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of DerbyUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 4 Feb 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.
Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions. The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Static posturography will assess the impacts of the exercise intervention on balance and stability.
Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults.
The study will establish the physical impact and practicalities of a novel elastic band resistance exercise intervention in older adults by performing force plate posturography and researcher led interviews that will focus on the participants perceptions of the activities and intensity levels to co-create an intervention that is accessible, acceptable, and appropriate for older adults.
Detailed description
Outline of study designThe following study will be a repeated measures design. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will not be recruited through HSN facilities or via any NHS platform. Participants will be required to attend three separate sessions with at least 48-72hours in between each session. Each session will be randomized in order to mitigate any bias and allow comparability of the 3 conditions. Experimental session one: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the hip region. Experimental session two: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the chest region. Experimental session three (control group): Participants will be required to perform pre-selected exercises without an elastic resistance band. The exercise intensity is measured throughout by RPE before, during and after each exercise.
intensity. Participants will be asked to simply perform the exercises not at any specific intensity. Force plate posturography measurements will be recorded before and immediately after and 30 minutes after the exercise intervention. The other quantitative measures (heart rate, rate of perceived exertion) will be recorded throughout the intervention and one-to-one interviews using a semi structured interview guide will be performed at the end of each session. The session order will be randomized for each participant to counterbalance the outcome which emerge from the study.
Participant preparation will include a detailed invitation to attend and briefing using a pre-prepared participant information sheet. Participants will be required to complete and return an International physical activity questionnaire, Falls efficacy scale, Confidence in maintaining balance and Instrumental Activities of Daily Living form.
Upon arrival of each session participants will be required to read and sign an informed consent form, a general health screen questionnaire and mini mental state examination. Participants will be required to complete all 3 sessions which will be supervised in the Kirtley building laboratory at the University of Derby (3 x experimental trial). Instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip Region | Experimental | Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the hip region. Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule |
| Chest Region | Experimental | Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest). Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule |
| No elastic band | Placebo comparator | Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant. Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
- Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
- Ability to walk without a walking aid
- Ability to provide consent. This will be determined by using the Mini Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired
Key exclusion criteria (5 listed)
- Individuals that are under the age of 50 years old
- Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
- Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are not physically active (METs score under 600 MET-min/ week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE).
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 |
|---|---|---|
| A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.Also: Elastic Resistance Band Training, Balance training in Older Adults, Stability Training using Resistance bands in Older Adults, The acute effects of using Elastic Resistance Bands in Older AdultsA repeated measures acute study using using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. Bertec force plate analysis will be performed to assess the acute effects on balance and stability. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences. | Device | Chest Region, Hip Region, No elastic band |
Primary outcome
Bertec Force plate posturography
Time frame: through study completion, an average of 1 year
Centre of pressure displacement and velocity parameters will be measured using a Bertec force plate and Pro-Vec software. Measurements include the position traces of anterior-posterior and mediolateral centre of pressure to provide feedback of postural stability. In particular, the mean displacement, root-mean-squared distance from mean, root-mean-square-velocity and the mean velocity of centre of pressure. Participants will stand upright and relaxed in the centre of a portable Bertec force plate with hands on hips and feet touching each other. Data will be collected under 4 different conditions: normal standing with eyes open, normal standing with eyes closed, a tandem stance with eyes open and a tandem stance with eyes closed. This will enable the proprioception and vestibular system to be assessed. Postural sway will be measured in the anteroposterior and mediolateral directions.
Semi structured Interview
Time frame: through study completion, an average of 1 year
A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol. Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement. This will help to build insights into the participant preferences which is an important element of the intervention design.
Heart rate
Time frame: through study completion, an average of 1 year
Heart rate measures will be taken during each exercise. Higher values = higher exertion of each exercise performed. 50 beats per min - 120 = low, 120- 150 beats per min = moderate and 150 beats per min = high.
Rate of perceived exertion (RPE)
Time frame: through study completion, an average of 1 year
RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion exhaustion.
3 secondary outcomes
Mini Balance Evaluation Test (MINI-BESTest)
Time frame: through study completeion, an average of 1 year
Short Falls efficacy scale (FES 1)
Time frame: through study completion, an average of 1 year
Balance Confidence Questionnaire (CONFbal)
Time frame: through study completion, an average of 1 year
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 11 Dec 2023.
- Results publication: PubMed 15304540Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
- Results publication: PubMed 11217890Carroll TJ, Barry B, Riek S, Carson RG. Resistance training enhances the stability of sensorimotor coordination. Proc Biol Sci. 2001 Feb 7;268(1464):221-7. doi: 10.1098/rspb.2000.1356.
- Results publication: PubMed 20703977Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.
- Results publication: PubMed 18714245Colado JC, Triplett NT. Effects of a short-term resistance program using elastic bands versus weight machines for sedentary middle-aged women. J Strength Cond Res. 2008 Sep;22(5):1441-8. doi: 10.1519/JSC.0b013e31817ae67a.
- Results publication: PubMed 11322678Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.
- Results publication: PubMed 28621015Gerards MHG, McCrum C, Mansfield A, Meijer K. Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice. Geriatr Gerontol Int. 2017 Dec;17(12):2294-2303. doi: 10.1111/ggi.13082. Epub 2017 Jun 16.
- Results publication: PubMed 29535589Lima FF, Camillo CA, Gobbo LA, Trevisan IB, Nascimento WBBM, Silva BSA, Lima MCS, Ramos D, Ramos EMC. Resistance Training using Low Cost Elastic Tubing is Equally Effective to Conventional Weight Machines in Middle-Aged to Older Healthy Adults: A Quasi-Randomized Controlled Clinical Trial. J Sports Sci Med. 2018 Mar 1;17(1):153-160. eCollection 2018 Mar.
- Results publication: PubMed 26048054Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
- Results publication: PubMed 17540020Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
- Results publication: PubMed 23921445Youdas JW, Adams KE, Bertucci JE, Brooks KJ, Nelson MM, Hollman JH. Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance. J Sport Rehabil. 2014 Feb;23(1):1-11. doi: 10.1123/jsr.2012-0082. Epub 2013 Aug 6.
- NHS balance exercisesLink provided by the sponsor.
- NHS Overview on FallsLink provided by the sponsor.
- National falls and fracture prevention strategy 2019-2024Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stability
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
Not yet recruitingPhase 2
Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer
Colorectal Cancer, Metastatic Colorectal Cancer
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.
Andy Pringle study director
University of Derby
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. in people with Stability and Posturography, run by University of Derby at 2 sites in United Kingdom.
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 4 inclusion and 5 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Bertec Force plate posturography (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224362, which also lists 10 linked publications.
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 11 Dec 2023.