Clinical trial NCT05106010: The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal
Official title: The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall Injury
Incontinence
Balance; Distorted
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 36
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women age 50 to 70 years of age

Brief 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. 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:

1. 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
2. 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:
3. 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?

Eligibility criteria: Inclusion Criteria:

* women, age 50 to 70 years

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Muscle Strength Grip Change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: Muscle Strength Shoulder and Elbow Change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: Muscle Strength Upper Body Change
timeFrame: 12 weeks
measure: Balance Change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: 30 second chair stand change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: one leg stand change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: modified clinical test of sensory interaction and balance change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: balance confidence change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: incontinence-ICIQ-UI short form and FLUTS change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: incontinence-pad test change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: range of motion change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: kyphosis change
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: reaction time
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
measure: biomechanical outcomes landing on outstretched hand
timeFrame: change assessed 12 weeks after baseline, and after 12 weeks of intervention
Secondary outcomes:
measure: perceptions of experience
timeFrame: 24 weeks after baseline
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References: