Elderly PopulationNCT04766112
Yang Style Tai Chi Exercises Combined With Mental Imagery Training On Balance and Fall Prevention in Older Adults
A study testing Group I and Group II in people with Elderly Population, run by Riphah International University at 1 site in Pakistan.
Trial summary
Aging process and the chronic diseases that affect older adults lead to balance disorders, which makes these individuals more susceptible to falls. However, currently there is no evidence available to support effects of Yang Style Tai Chi exercises combined with mental imagery training on balance and fall prevention… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Elderly Population
- What is being tested?
- Group I and Group II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Apr 2021
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 60
- Be referred for a fall problem.
- Be identified as being at high risk for a fall on the initial medical assessment (Berg balance scale less than 40/56and at least one accidental fall in the previous 6 month
- Be mentally able to take in an exercise program as assessed with the final SMMSE score is a sum of the 12 items, and can range from a minimum of 0 to a maximum of 30. The SMMSE can be adjusted for non-cognitive disabilities.
Who cannot join
- Declared unfit for physical activities following medical assessment.
- Present a mental or physical condition incompatible with physical activity.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bashart hospital Rawalpindi.
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Yang Style Tai Chi Exercises Combined With Mental Imagery Training On Balance and Fall Prevention in Older Adults
Aging process and the chronic diseases that affect older adults lead to balance disorders, which makes these individuals more susceptible to falls. However, currently there is no evidence available to support effects of Yang Style Tai Chi exercises combined with mental imagery training on balance and fall prevention in older adults. Because separately Tai Chi training techniques having good effects according to evidence .So in this study we will be find out the effects of Tai chi with mental imagery training for the selection of most appropriate treatment method.
Read the detailed description
Fall is defined as any unintentional positional change that results in a person coming to rest on the ground, floor, or other lower surface. The risk of fall increase dramatically with age. In older adults unintentionally injuries are the fifth leading cause of death, and falls constitute two thirds of these days.
Falls are most serious common condition present in older adults. Falls and balanced problem are more common in elder population, causing injuries, social isolation, and psychological difficulties. Proper balance is imperative for the performance of functional activities. Any deficiency or impairment in balance increases the risk of fall thus making it difficult to perform functional activities. Balance is defined as exertion of postural control that provides a stable base of support while remaining stationary or during movement. Decrease in balance ability resulting from aging triggers motor and gait disabilities in elderly people, which greatly affects their mobility in day-to-day life. They are the serious cause of mortality and morbidity which leads to immobility and premature nursing care.
As life expectancy increases, the problem of falls among the elderly will become more pertinent. Falls occurred in more than one third of the elderly aged 65 years and older annually. The incidence of falls rises steadily from Middle age and peaks in persons older than 80 years. The frequency of falls increases with age and frailty level. Older people who are living in nursing homes fall more often than those who are living in the community. Approximately 30-50% of people living in long term care institutions fall each year, and 40% of them experienced recurrent fall. Approximately 25% to 35% of people over age 65 years experiences more falls every year. Older people have stiffer, less coordinated and more dangerous gaits than younger people. Risk factors for falls among elderly people include environmental hazards and housing characteristic. There are several factors that may influence the fall risk in the elderly to a great extent. Environmental hazards are the leading cause of falls, accounting for about 25 to 45 percent in most studies. Major risk factor of fall among elderly population weakness, mobility impairment, balance and gait disturbance, Dizziness, vertigo, drop attacks, postural hypotension, visual impairment, and syncope are known to cause falls. Attention to these factors significantly reduce the risk of fall. Lower extremity muscle weakness is a significant risk factor for falls, increasing the odds of falling fourfold. A history of fall and gait or balance deficits increases the risk threefold.
Other high-risk situations that can cause or contribute to falls are use of an assistive device, visual deficit, arthritis, and impaired activities of daily living, depression, cognitive impairment, and age older than 80 years. Use of four or more medications has been strongly associated with an increased risk of falls. In particular, use of psychotropic medications, cardiac drugs including class 1A antiarrhythmic agents, digoxin, diuretics, and anticonvulsants have been Implicated in increasing the risk of falls.
There is paucity in the literature regarding evidence for the effectiveness of Tai chi exercises in older adults Lin YC et al 2019 found that in both cross sectional and longitudinal studies that Tai Chi exercises has more effectiveness in balance control, psychological wellbeing ,cardiovascular fitness and postural stability than other exercises. These findings shows that Tai chi exercises has more beneficial and health effective to maintain the good, physical, psychological conditions in older adults.In previous studies have shown beneficial effects of Tai Chi on cardiorespiratory system ,flexibility, Muscle strength, and body fat composition in middle aged and elderly individuals. Likewise, Hong and colleagues found that older adults who had been practicing Tai Chi Chuan for an average of 13.2 years had better balance and functional fitness compared to sedentary older adults. In 2015 Rahal et al in this study 76 elderly individuals who were divided into two groups: the Tai Chi Chuan Group and the Dance Group. The subjects were tested using the Neuro Com Balance MasterH force platform system with the following protocols: static balance testsand dynamic balance tests and found that older expert Tai Chi Chuan practitioners had better bilateral static balance with eyes open on firm and foam surfaces compared to dancers.
A study was done by Cho HY, et al. with the title of Effects of motor imagery training on balance and gait abilities in post-stroke patients published in 2013 and concluded that Adding motor imagery training to gait training produced more significant improvements in the balance and gait abilities than gait training in stroke subjects.
Another study was done by Hamel MF, et al. in 2005 and concluded that the link between attentional demands, postural oscillations, static balance and the prevention of falls among the elderly is of importance. The reduction of attentional demands reflects the automaticity of a task. Therefore, when attentional demands are reduced, more attentional resources are unbound to avoid, among other things, the environmental risk factors that can lead to falls. It has been shown that mental imagery is an effective technique, not only in reducing antero-posterior postural oscillations, but also in interpreting the postural control tasks more automatic. Therefore, this technique may be considered effective among the elderly population, in order to contribute to improving their static balance and preventing falls.
A study was done by Page SJ, et.al with the title of a randomized efficacy and feasibility study of imagery in acute stroke. Published in 2001 and concluded that Imagery technique is a clinically feasible intervention and Imagery, in association with therapy, appears to be a noninvasive, efficacious complement to traditional therapy
- Conditions
- Elderly Population
- Being tested
- Group I, Group II
- Keywords
- Balance, Yang Style Tai Chi Exercises, mental imagery training, elderly population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IOther
Group I will receive yang style Tai chi exercises combined with mental imagery training
Group IIOther
Group II will receive yang style Tai chi exercise which consist of 10 positions.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I will receive yang style Tai chi exercises combined with mental imagery training which consist of 10 positions Receives: Other: Group II |
| Group II | Active comparator | Group B will receive yang style Tai chi exercise which consist of 10 positions Receives: Other: Group I |
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 one of the most widely used tools for balance assessment.
Measured: Change from Baseline , balance to 4Weeks, 8 weeks
Fall efficacy Scale
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity.
Measured: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
Secondary outcomes (1)
Timed Up and Go test (TUG):
TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with arm rests, walk 3 m, turn, walk back to the chair, and sit down
Measured: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Elderly PopulationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766112
- Sponsor's protocol ID
- REC/00745 Farah Naqvi
- Status last verified
- Jun 2021
- First submitted
- 18 Feb 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moylan KC, Binder EF. Falls in older adults: risk assessment, management and prevention. Am J Med. 2007 Jun;120(6):493.e1-6. doi: 10.1016/j.amjmed.2006.07.022.
PubMed 17524747Cameron ID, Dyer SM, Panagoda CE, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database Syst Rev. 2018 Sep 7;9(9):CD005465. doi: 10.1002/14651858.CD005465.pub4.
PubMed 30191554Ibrahim MS, Mattar AG, Elhafez SM. Efficacy of virtual reality-based balance training versus the Biodex balance system training on the body balance of adults. J Phys Ther Sci. 2016 Jan;28(1):20-6. doi: 10.1589/jpts.28.20. Epub 2016 Jan 30.
PubMed 26957722Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
PubMed 16926202Voermans NC, Snijders AH, Schoon Y, Bloem BR. Why old people fall (and how to stop them). Pract Neurol. 2007 Jun;7(3):158-71. doi: 10.1136/jnnp.2007.120980. No abstract available.
PubMed 17515595Blake AJ, Morgan K, Bendall MJ, Dallosso H, Ebrahim SB, Arie TH, Fentem PH, Bassey EJ. Falls by elderly people at home: prevalence and associated factors. Age Ageing. 1988 Nov;17(6):365-72. doi: 10.1093/ageing/17.6.365.
PubMed 3266440
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yang Style Tai Chi Exercises Combined With Mental Imagery Training On Balance and Fall Prevention in Older Adults
- ClinicalTrials.gov ID
- NCT04766112
- Acronym / sponsor ID
- REC/00745 Farah Naqvi
- Conditions
- Elderly Population
- Keywords
- Balance, Yang Style Tai Chi Exercises, mental imagery training, elderly population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Feb 2021 (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.
Aging process and the chronic diseases that affect older adults lead to balance disorders, which makes these individuals more susceptible to falls. However, currently there is no evidence available to support effects of Yang Style Tai Chi exercises combined with mental imagery training on balance and fall prevention in older adults. Because separately Tai Chi training techniques having good effects according to evidence .So in this study we will be find out the effects of Tai chi with mental imagery training for the selection of most appropriate treatment method.
Detailed description
Fall is defined as any unintentional positional change that results in a person coming to rest on the ground, floor, or other lower surface. The risk of fall increase dramatically with age. In older adults unintentionally injuries are the fifth leading cause of death, and falls constitute two thirds of these days.
Falls are most serious common condition present in older adults. Falls and balanced problem are more common in elder population, causing injuries, social isolation, and psychological difficulties. Proper balance is imperative for the performance of functional activities. Any deficiency or impairment in balance increases the risk of fall thus making it difficult to perform functional activities. Balance is defined as exertion of postural control that provides a stable base of support while remaining stationary or during movement. Decrease in balance ability resulting from aging triggers motor and gait disabilities in elderly people, which greatly affects their mobility in day-to-day life. They are the serious cause of mortality and morbidity which leads to immobility and premature nursing care.
As life expectancy increases, the problem of falls among the elderly will become more pertinent. Falls occurred in more than one third of the elderly aged 65 years and older annually. The incidence of falls rises steadily from Middle age and peaks in persons older than 80 years. The frequency of falls increases with age and frailty level. Older people who are living in nursing homes fall more often than those who are living in the community. Approximately 30-50% of people living in long term care institutions fall each year, and 40% of them experienced recurrent fall. Approximately 25% to 35% of people over age 65 years experiences more falls every year. Older people have stiffer, less coordinated and more dangerous gaits than younger people. Risk factors for falls among elderly people include environmental hazards and housing characteristic. There are several factors that may influence the fall risk in the elderly to a great extent. Environmental hazards are the leading cause of falls, accounting for about 25 to 45 percent in most studies. Major risk factor of fall among elderly population weakness, mobility impairment, balance and gait disturbance, Dizziness, vertigo, drop attacks, postural hypotension, visual impairment, and syncope are known to cause falls. Attention to these factors significantly reduce the risk of fall. Lower extremity muscle weakness is a significant risk factor for falls, increasing the odds of falling fourfold. A history of fall and gait or balance deficits increases the risk threefold.
Other high-risk situations that can cause or contribute to falls are use of an assistive device, visual deficit, arthritis, and impaired activities of daily living, depression, cognitive impairment, and age older than 80 years. Use of four or more medications has been strongly associated with an increased risk of falls. In particular, use of psychotropic medications, cardiac drugs including class 1A antiarrhythmic agents, digoxin, diuretics, and anticonvulsants have been Implicated in increasing the risk of falls.
There is paucity in the literature regarding evidence for the effectiveness of Tai chi exercises in older adults Lin YC et al 2019 found that in both cross sectional and longitudinal studies that Tai Chi exercises has more effectiveness in balance control, psychological wellbeing ,cardiovascular fitness and postural stability than other exercises. These findings shows that Tai chi exercises has more beneficial and health effective to maintain the good, physical, psychological conditions in older adults.In previous studies have shown beneficial effects of Tai Chi on cardiorespiratory system ,flexibility, Muscle strength, and body fat composition in middle aged and elderly individuals. Likewise, Hong and colleagues found that older adults who had been practicing Tai Chi Chuan for an average of 13.2 years had better balance and functional fitness compared to sedentary older adults. In 2015 Rahal et al in this study 76 elderly individuals who were divided into two groups: the Tai Chi Chuan Group and the Dance Group. The subjects were tested using the Neuro Com Balance MasterH force platform system with the following protocols: static balance testsand dynamic balance tests and found that older expert Tai Chi Chuan practitioners had better bilateral static balance with eyes open on firm and foam surfaces compared to dancers.
A study was done by Cho HY, et al. with the title of Effects of motor imagery training on balance and gait abilities in post-stroke patients published in 2013 and concluded that Adding motor imagery training to gait training produced more significant improvements in the balance and gait abilities than gait training in stroke subjects.
Another study was done by Hamel MF, et al. in 2005 and concluded that the link between attentional demands, postural oscillations, static balance and the prevention of falls among the elderly is of importance. The reduction of attentional demands reflects the automaticity of a task. Therefore, when attentional demands are reduced, more attentional resources are unbound to avoid, among other things, the environmental risk factors that can lead to falls. It has been shown that mental imagery is an effective technique, not only in reducing antero-posterior postural oscillations, but also in interpreting the postural control tasks more automatic. Therefore, this technique may be considered effective among the elderly population, in order to contribute to improving their static balance and preventing falls.
A study was done by Page SJ, et.al with the title of a randomized efficacy and feasibility study of imagery in acute stroke. Published in 2001 and concluded that Imagery technique is a clinically feasible intervention and Imagery, in association with therapy, appears to be a noninvasive, efficacious complement to traditional therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Group IIGroup I will receive yang style Tai chi exercises combined with mental imagery training which consist of 10 positions |
| Group II | Active comparator | Other: Group IGroup B will receive yang style Tai chi exercise which consist of 10 positions |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 60
- Be referred for a fall problem.
- Be identified as being at high risk for a fall on the initial medical assessment (Berg balance scale less than 40/56and at least one accidental fall in the previous 6 month
- Be mentally able to take in an exercise program as assessed with the final SMMSE score is a sum of the 12 items, and can range from a minimum of 0 to a maximum of 30. The SMMSE can be adjusted for non-cognitive disabilities.
Key exclusion criteria (2 listed)
- Declared unfit for physical activities following medical assessment.
- Present a mental or physical condition incompatible with physical activity.
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 |
|---|---|---|
| Group IGroup I will receive yang style Tai chi exercises combined with mental imagery training | Other | Group II |
| Group IIGroup II will receive yang style Tai chi exercise which consist of 10 positions. | Other | Group I |
Primary outcome
Berg Balance Scale:
Time frame: Change from Baseline , balance to 4Weeks, 8 weeks
The Berg Balance Scale (BBS) is one of the most widely used tools for balance assessment.
Fall efficacy Scale
Time frame: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity.
1 secondary outcome
Timed Up and Go test (TUG):
Time frame: Change from Baseline , balance and fall prevention to 4Weeks, 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 30 Jun 2021.
- Background: PubMed 17524747Moylan KC, Binder EF. Falls in older adults: risk assessment, management and prevention. Am J Med. 2007 Jun;120(6):493.e1-6. doi: 10.1016/j.amjmed.2006.07.022.
- Background: PubMed 30191554Cameron ID, Dyer SM, Panagoda CE, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database Syst Rev. 2018 Sep 7;9(9):CD005465. doi: 10.1002/14651858.CD005465.pub4.
- Background: PubMed 26957722Ibrahim MS, Mattar AG, Elhafez SM. Efficacy of virtual reality-based balance training versus the Biodex balance system training on the body balance of adults. J Phys Ther Sci. 2016 Jan;28(1):20-6. doi: 10.1589/jpts.28.20. Epub 2016 Jan 30.
- Background: PubMed 16926202Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
- Background: PubMed 17515595Voermans NC, Snijders AH, Schoon Y, Bloem BR. Why old people fall (and how to stop them). Pract Neurol. 2007 Jun;7(3):158-71. doi: 10.1136/jnnp.2007.120980. No abstract available.
- Background: PubMed 3266440Blake AJ, Morgan K, Bendall MJ, Dallosso H, Ebrahim SB, Arie TH, Fentem PH, Bassey EJ. Falls by elderly people at home: prevalence and associated factors. Age Ageing. 1988 Nov;17(6):365-72. doi: 10.1093/ageing/17.6.365.
- 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.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I and Group II in people with Elderly Population, run by Riphah International University at 1 site in Pakistan.
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 2 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 30 Jun 2021. 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 Pakistan. 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?
Berg Balance Scale: (time frame: Change from Baseline , balance to 4Weeks, 8 weeks). The study lists 2 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 NCT04766112, which also lists 6 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 30 Jun 2021.