Clinical trial NCT03885466: Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Official title: Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Hyperkyphosis
Vertebral Fracture
Keywords: Nordic walking
Osteoporosis
Hyperkyphosis
Vertebral Fracture
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Royal University Hospital Foundation
name: Saskatchewan Health Research Foundation
name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2019-03-21
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group randomized control trial will be used to test our hypotheses. Participants randomized to the waiting-list control group will serve as controls for the baseline and 3-month measurements. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.
Primary purpose: TREATMENT

Brief summary: Nordic walking is currently offered by a number of health care practitioners as a form of exercise therapy for older adults at risk of fracture. These include older individuals with osteoporosis, previous vertebral fracture, or hyperkyphosis. To the investigators knowledge, this practice is not evidence-based and thus potentially problematic as benefits and safety of Nordic walking for individuals with osteoporosis, fractures, or hyperkyphosis are unknown. The proposed study will answer the following principal question: Does Nordic walking improve mobility, physical function, posture, and quality of life for ambulant community dwelling individuals who have osteoporosis, a history of osteoporotic fracture, or hyperkyphosis? Participants will be randomized into either the Nordic walking intervention group, or the waiting-list control group. Participants will initially train 3 times per week for 3 months, led by peer- and/or student-instructors. The Nordic walking training will depend on the participant's skill and comfort level and will consist of walking with poles over a distance set individually for each participant. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.

Detailed description: The investigators will include 160 individuals who have been diagnosed with osteoporosis, have history of osteoporotic fracture or hyperkyphosis (hunched-back posture). Participants will be randomized to either a Nordic walking intervention group or a waiting-list control group (the latter group will receive same intervention after the trial is completed). The pole-walking intervention will be 12 weeks in duration, including 3 weekly Nordic walking sessions (warm up, Nordic walking with posture and leg strengthening exercises and stretches) tailored to each participants. The investigators will define osteoporosis status at baseline (via DXA scans). The investigators will compare between group changes in dynamic balance, posture, quality of life, mobility, muscle strength, size and composition (using low radiation CT scans) after 3 months of Nordic walking intervention.

Eligibility criteria: Eligibility criteria for study participants:

* diagnosis of osteoporosis, past vertebral fracture or hyperkyphosis
* ambulatory (without the use of assistive devices)
* not currently involved in moderate-vigorous exercise training, including Nordic walking, more than once per week
* must not be diagnosed with Parkinson's disease

Primary outcomes:
measure: Functional balance
timeFrame: 3-5 minutes
measure: Quality of life score
timeFrame: 5-10 minutes
measure: Kyphosis angle
timeFrame: 2-3 minutes
Secondary outcomes:
measure: Muscle strength
timeFrame: 2-4 minutes
measure: Mobility
timeFrame: 16-20 minutes
measure: Bone and muscle properties and estimated bone strength of the lower leg and forearm
timeFrame: 20-30 minutes
measure: Total body lean tissue mass (g)
timeFrame: 10-20 minutes
measure: Proximal femur bone mineral density (g/cm^2)
timeFrame: 10-20 minutes
measure: Kyphosis angle
timeFrame: 3-5 minutes
measure: Physical activity exercise confidence
timeFrame: 2-5 minutes
measure: Fear of falling
timeFrame: 2-5 minutes
measure: Physical activity
timeFrame: 7 days
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Saija Kontulainen, PhD
role: PRINCIPAL_INVESTIGATOR
References: