Fall InjuryNCT05106010
The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal
An observational study of Fall Injury and Incontinence, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the effect of yoga on both fall risk factors AND capacity to successfully control landing and descent during a simulated fall among peri-and post- menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fall Injury, Incontinence, Balance; Distorted
- What is being tested?
- Balance Flow Yoga
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 15 Feb 2020
- Phase
- Observational
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women age 50 to 70 years of age
Who may be able to join
- women, age 50 to 70 years
Who cannot join
- participation in yoga twice per week or more in the past three months
- any recent upper extremity (UE), neck or back injury, or other painful joint problem that significantly limits day to day activities
- distal radius fracture in the past two years, any fracture in the past year, or a history of multiple fractures of the wrist or forearm
- any history of UE neurological problems (i.e. Stroke, Multiple Sclerosis, Parkinson's disease, reflex neuropathy)
- any cardio-vascular problems that would contradict maximum effort strength assessment
- presence of a joint replacement (i.e. hip or knee)
- unable to safely ambulate independently (with or without a walking aid) in the community.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the effect of yoga on both fall risk factors AND capacity to successfully control landing and descent during a simulated fall among peri-and post- menopausal women. Older women are particularly vulnerable to sustaining fall-related injuries and although targeted exercises focusing on balance and strength may decrease the risk of falls, the ideal type of intervention to prevent injury when a fall is unavoidable is not known. Yoga is an increasingly popular health practice with potential benefits linked to improving balance, muscle strength and quality of life, but there is no evidence that yoga can improve the capacity to reduce the risk of fall-related injury. Such evidence will help to inform health promotion and fall/injury risk management for older adults.
Read the detailed description
Falls are the leading cause of injury hospitalization for older adults in Canada. Determining effective and feasible community-based interventions is important to prevent the downward spiral of failing health, admission to long term care and even death following a serious fall-related injury. Women in their 50s and 60s are particularly vulnerable to sustaining fall-related injuries such as fractures. Our research team has identified early signs of fall risk in women aged 50 to 65 years. Exercise is known to decrease fall risk in community-dwelling older adults when components of balance, strength and agility are included, but the evidence is not clear on the effect of different types of exercise on decreasing fall-related injury risk particularly for older women at risk in their peri-menopausal and early post-menopausal years.
The risk of injury from falls depends on both the severity of impact and neuromuscular capacity such as bone and muscle strength of the affected body part. Most falls in community-dwelling older women occur in a forward direction. Forward falls are typically combined with hand contact as a protective response to prevent head, hip or torso injury. Evidence from the investigators' research team suggests that women in their 60s and 70s years do not have the same capacity to control a safe landing and decrease force impact compared to women in their 20s or 30s.Older women also demonstrate diminished activation of the abdominal core muscles prior to an unexpected simulated fall. The impact of diminished pelvic floor muscle control could also be a contributing factor to fall and injury risk in peri- and post-menopausal women as it has been associated with decreased balance, urinary incontinence and fall risk.
Yoga is a common recreational choice for peri- and post-menopausal women. Reasons could include a range of health improvements such as easing menopausal symptoms, improving pelvic floor dysfunctions such as incontinence or pelvic pain, enhancing bone loading to combat early osteoporosis, and improving overall quality of life. Yoga has also been associated with benefits to decrease fall risk; however, there is no substantive evidence that these outcomes result in a decrease in fall rates or a reduction in the injuries associated with falling.
Yoga, a system of health that promotes physical, mental, emotional, social and spiritual well-being, may offer unique benefits to decrease both fall risk and injury risk in the event a fall is unavoidable. Hatha yoga includes physical poses, mindful movement, breath awareness and regulation practices that can address balance, flexibility, and promote upper body loading and whole body strength training. The additional focus on abdominal and pelvic floor core control and breath techniques during functional movement may also promote motor control important in the maintenance of balance and enhance protective responses and landing strategies. The positive mental health focus and meditative component of linking physical postures and movement to breath could also help to improve balance confidence and decrease fear of falls. Yoga has multiple promising benefits to decrease the risk of fall-related injury in older women but there remains gaps in the literature to substantiate these claims.
The primary research questions are:
- What is the effect of 12 weeks of hatha yoga on fall risk factors in peri- and post-menopausal women? (balance, balance confidence, functional mobility, muscle strength, incontinence leakage, symptoms and bother) and
- Does 12 weeks of hatha yoga improve capacity to land and control the descent of a forward fall in peri- and post-menopausal women? (muscle activation, range of motion, reaction time, and energy absorption). Secondary research questions will explore:
- What are the perceived changes in general health, fall risk, menopausal symptoms and incontinence for women who participate in yoga? What are the motivators, facilitators and barriers for participation in a regular yoga practice?
- Conditions
- Fall Injury, Incontinence, Balance; Distorted
- Being tested
- Balance Flow Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Flow YogaOther
The yoga class is based on hatha yoga which includes physical poses and mindful movement integrated with breath. Conducted in a local yoga studio for 75 minutes duration, twice per week and also open to the public. The specific yoga techniques reflect the objectives of our study and focus on addressing some of the physical, mental and emotional factors that potentially contribute to falls such as balance, balance confidence, strength, coordination, proprioception, core training strategies, and breathing techniques integrated with mindfulness practices and yoga philosophy. The practices will incorporate a combination of seated, kneeling, standing and lying postures and transitions between positions with individual modifications provided on an as-needed basis. The yoga classes will be co-designed by registered yoga teachers and taught by two trained and experienced and yoga teachers blinded to study testing measures.
| Study group | Role | What they receive |
|---|---|---|
| Usual Activity | Participants continued with usual activity, not participating in any yoga intervention for 12 weeks | |
| Balance Flow Yoga | Community hatha yoga flow class, 75 minutes duration, twice per week for 12 weeks Receives: Other: Balance Flow Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Grip Change
Grip strength using a hand held dynamometer
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Muscle Strength Shoulder and Elbow Change
Shoulder flexion, abduction and elbow extension using hand-held dynamometer
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Muscle Strength Upper Body Change
concentric and eccentric upper body strength test using isokinetic dynamometer
Measured: 12 weeks
Balance Change
mini-BESTest, comprehensive balance assessment of four balance systems
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
30 second chair stand change
number of sit to stand motions in 30 sec
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
one leg stand change
seconds standing on one leg, up to 60 sec
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
modified clinical test of sensory interaction and balance change
four balance conditions, maximum score = 120 seconds, meaning better balance
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
balance confidence change
activities balance confidence scale (ABC) maximum score 100 meaning higher confidence
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
incontinence-ICIQ-UI short form and FLUTS change
International Consultation on Incontinence Modular Questionnaire and the Urinary Incontinence short form; includes symptoms of bother, stress and urge. It is scored on a scale from 0-16 for symptoms of filling, 0-12 for voiding symptoms and 0-20 for incontinence symptoms
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
incontinence-pad test change
weight (grams) of pad pre and post water consumption and activity protocol
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
range of motion change
wrist extension and shoulder extension using goniometer (degrees)
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
kyphosis change
thoracic kyphosis index with flexicurve ruler (degrees)
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
reaction time
time (seconds) from hand motion to touching forceplate at shoulder level in standing
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
biomechanical outcomes landing on outstretched hand
impact force, energy absorption, range of motion, torque in both controlled and unexpected descent in a simulated forward fall lab apparatus
Measured: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Secondary outcomes (1)
perceptions of experience
benefits, challenges and experiences determined from focus groups (qualitative)
Measured: 24 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2018
- Primary completion15 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnold, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106010
- Sponsor's protocol ID
- Bio 17-64
- Status last verified
- Oct 2021
- First submitted
- 25 Aug 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests can be made to PI
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal
- ClinicalTrials.gov ID
- NCT05106010
- Acronym / sponsor ID
- Bio 17-64
- Conditions
- Fall Injury, Incontinence, Balance; Distorted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 3 Nov 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.
The primary objective of this study is to evaluate the effect of yoga on both fall risk factors AND capacity to successfully control landing and descent during a simulated fall among peri-and post- menopausal women. Older women are particularly vulnerable to sustaining fall-related injuries and although targeted exercises focusing on balance and strength may decrease the risk of falls, the ideal type of intervention to prevent injury when a fall is unavoidable is not known. Yoga is an increasingly popular health practice with potential benefits linked to improving balance, muscle strength and quality of life, but there is no evidence that yoga can improve the capacity to reduce the risk of fall-related injury. Such evidence will help to inform health promotion and fall/injury risk management for older adults.
Detailed description
Falls are the leading cause of injury hospitalization for older adults in Canada. Determining effective and feasible community-based interventions is important to prevent the downward spiral of failing health, admission to long term care and even death following a serious fall-related injury. Women in their 50s and 60s are particularly vulnerable to sustaining fall-related injuries such as fractures. Our research team has identified early signs of fall risk in women aged 50 to 65 years. Exercise is known to decrease fall risk in community-dwelling older adults when components of balance, strength and agility are included, but the evidence is not clear on the effect of different types of exercise on decreasing fall-related injury risk particularly for older women at risk in their peri-menopausal and early post-menopausal years.
The risk of injury from falls depends on both the severity of impact and neuromuscular capacity such as bone and muscle strength of the affected body part. Most falls in community-dwelling older women occur in a forward direction. Forward falls are typically combined with hand contact as a protective response to prevent head, hip or torso injury. Evidence from the investigators' research team suggests that women in their 60s and 70s years do not have the same capacity to control a safe landing and decrease force impact compared to women in their 20s or 30s.Older women also demonstrate diminished activation of the abdominal core muscles prior to an unexpected simulated fall. The impact of diminished pelvic floor muscle control could also be a contributing factor to fall and injury risk in peri- and post-menopausal women as it has been associated with decreased balance, urinary incontinence and fall risk.
Yoga is a common recreational choice for peri- and post-menopausal women. Reasons could include a range of health improvements such as easing menopausal symptoms, improving pelvic floor dysfunctions such as incontinence or pelvic pain, enhancing bone loading to combat early osteoporosis, and improving overall quality of life. Yoga has also been associated with benefits to decrease fall risk; however, there is no substantive evidence that these outcomes result in a decrease in fall rates or a reduction in the injuries associated with falling.
Yoga, a system of health that promotes physical, mental, emotional, social and spiritual well-being, may offer unique benefits to decrease both fall risk and injury risk in the event a fall is unavoidable. Hatha yoga includes physical poses, mindful movement, breath awareness and regulation practices that can address balance, flexibility, and promote upper body loading and whole body strength training. The additional focus on abdominal and pelvic floor core control and breath techniques during functional movement may also promote motor control important in the maintenance of balance and enhance protective responses and landing strategies. The positive mental health focus and meditative component of linking physical postures and movement to breath could also help to improve balance confidence and decrease fear of falls. Yoga has multiple promising benefits to decrease the risk of fall-related injury in older women but there remains gaps in the literature to substantiate these claims.
The primary research questions are:
- What is the effect of 12 weeks of hatha yoga on fall risk factors in peri- and post-menopausal women? (balance, balance confidence, functional mobility, muscle strength, incontinence leakage, symptoms and bother) and
- Does 12 weeks of hatha yoga improve capacity to land and control the descent of a forward fall in peri- and post-menopausal women? (muscle activation, range of motion, reaction time, and energy absorption). Secondary research questions will explore:
- What are the perceived changes in general health, fall risk, menopausal symptoms and incontinence for women who participate in yoga? What are the motivators, facilitators and barriers for participation in a regular yoga practice?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Activity | – | –Participants continued with usual activity, not participating in any yoga intervention for 12 weeks |
| Balance Flow Yoga | – | Other: Balance Flow YogaCommunity hatha yoga flow class, 75 minutes duration, twice per week for 12 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women age 50 to 70 years of age
Key inclusion criteria (1 listed)
- women, age 50 to 70 years
Key exclusion criteria (7 listed)
- participation in yoga twice per week or more in the past three months
- any recent upper extremity (UE), neck or back injury, or other painful joint problem that significantly limits day to day activities
- distal radius fracture in the past two years, any fracture in the past year, or a history of multiple fractures of the wrist or forearm
- any history of UE neurological problems (i.e. Stroke, Multiple Sclerosis, Parkinson's disease, reflex neuropathy)
- any cardio-vascular problems that would contradict maximum effort strength assessment
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 |
|---|---|---|
| Balance Flow YogaThe yoga class is based on hatha yoga which includes physical poses and mindful movement integrated with breath. Conducted in a local yoga studio for 75 minutes duration, twice per week and also open to the public. The specific yoga techniques reflect the objectives of our study and focus on addressing some of the physical, mental and emotional factors that potentially contribute to falls such as balance, balance confidence, strength, coordination, proprioception, core training strategies, and breathing techniques integrated with mindfulness practices and yoga philosophy. The practices will incorporate a combination of seated, kneeling, standing and lying postures and transitions between positions with individual modifications provided on an as-needed basis. The yoga classes will be co-designed by registered yoga teachers and taught by two trained and experienced and yoga teachers blinded to study testing measures. | Other | Balance Flow Yoga |
Primary outcome
Muscle Strength Grip Change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Grip strength using a hand held dynamometer
Muscle Strength Shoulder and Elbow Change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Shoulder flexion, abduction and elbow extension using hand-held dynamometer
Muscle Strength Upper Body Change
Time frame: 12 weeks
concentric and eccentric upper body strength test using isokinetic dynamometer
Balance Change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
mini-BESTest, comprehensive balance assessment of four balance systems
30 second chair stand change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
number of sit to stand motions in 30 sec
one leg stand change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
seconds standing on one leg, up to 60 sec
modified clinical test of sensory interaction and balance change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
four balance conditions, maximum score = 120 seconds, meaning better balance
balance confidence change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
activities balance confidence scale (ABC) maximum score 100 meaning higher confidence
incontinence-ICIQ-UI short form and FLUTS change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
International Consultation on Incontinence Modular Questionnaire and the Urinary Incontinence short form; includes symptoms of bother, stress and urge. It is scored on a scale from 0-16 for symptoms of filling, 0-12 for voiding symptoms and 0-20 for incontinence symptoms
incontinence-pad test change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
weight (grams) of pad pre and post water consumption and activity protocol
range of motion change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
wrist extension and shoulder extension using goniometer (degrees)
kyphosis change
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
thoracic kyphosis index with flexicurve ruler (degrees)
reaction time
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
time (seconds) from hand motion to touching forceplate at shoulder level in standing
biomechanical outcomes landing on outstretched hand
Time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
impact force, energy absorption, range of motion, torque in both controlled and unexpected descent in a simulated forward fall lab apparatus
1 secondary outcome
perceptions of experience
Time frame: 24 weeks after baseline
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 3 Nov 2021.
- Individual participant dataSharing planned: No. Requests can be made to PI
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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?
An observational study of Fall Injury and Incontinence, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 7 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 3 Nov 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 Canada. 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?
Muscle Strength Grip Change (time frame: change assessed 12 weeks after baseline, and after 12 weeks of intervention). The study lists 14 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 3 Nov 2021.