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Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03885466
Enrollment
117
Registered
2019-03-21
Start date
2019-10-18
Completion date
2023-12-21
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperkyphosis, Osteoporosis, Vertebral Fracture

Keywords

Nordic walking, Osteoporosis, Hyperkyphosis, Vertebral Fracture

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.

Interventions

Participants will initially train 3 times per week for 3 months. Training sessions will be led by trained peer- and/or student-instructors. Nordic walking sessions (starting at 20 and progressing to 60min/session) will include a warm-up, strengthening, and dynamic balance and stretching exercises in addition to Nordic walking, as per the Saskatoon Health Region guide (Saskatoon Health Region, 2014). Training (distance and intensity) will be progressive and individually set.

Sponsors

Royal University Hospital Foundation
CollaboratorOTHER
Saskatchewan Health Research Foundation
CollaboratorOTHER
Saskatchewan Centre for Patient-Oriented Research
CollaboratorOTHER
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Research assistants and technicians collecting data will be blinded as to whether participants are in the exercise or control group. Participants will not be blinded for Nordic walking. All methods and reporting of the trial will follow Consolidated Standards of Reporting Trials (CONSORT) guidelines.

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Functional balance3-5 minutesAssessed by timed up and go test (TUG)
Quality of life score5-10 minutesAssessed by 36-Item Short Form Survey (SF-36). Survey consists of 36 questions with 8 sub-scales: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Responses range from 1-6 and are scored according to a key that values each answer from 0-100, where higher values are better outcomes. The average score of each sub-scale is recorded.
Kyphosis angle2-3 minutesAssessed using kyphometer

Secondary

MeasureTime frameDescription
Mobility16-20 minutesAssessed by 6-minute walking test
Bone and muscle properties and estimated bone strength of the lower leg and forearm20-30 minutesAssessed by peripheral quantitative computed tomography (pQCT)
Kyphosis angle3-5 minutesAssessed by flexicurve
Total body lean tissue mass (g)10-20 minutesAssessed by dual-energy X-ray absorptiometry (DXA)
Fear of falling2-5 minutesAssessed by the 10-item falls efficacy scale. Scale consists of 10 questions with responses ranging from 1 (not confident at all) to 10 (very confident). Higher values are better outcomes. Sub-scale values are summed and total value is recorded.
Physical activity7 daysRecording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring
Physical activity exercise confidence2-5 minutesAssessed by the Exercise self-efficacy scale. Scale consists of 10 questions with responses ranging from 1 (not confident at all) to 7 (very confident). Higher values are better outcomes. Sub-scale values are summed and total value is recorded.
Proximal femur bone mineral density (g/cm^2)10-20 minutesAssessed by dual-energy X-ray absorptiometry (DXA)
Muscle strength2-4 minutesAssessed by sit-to-stand test

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026