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Completed

NCT Number: NCT03885466

Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

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.

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Key information

Conditions

Osteoporosis Back Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Hyperkyphosis Kyphosis Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Curvatures Spinal Diseases Spinal Fractures Spinal Injuries Vertebral Fracture Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nordic Walking exercise

Behavioral

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.

Primary outcomes

  1. Functional balance

    Time frame: 3-5 minutes

    Assessed by timed up and go test (TUG)

  2. Quality of life score

    Time frame: 5-10 minutes

    Assessed 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.

  3. Kyphosis angle

    Time frame: 2-3 minutes

    Assessed using kyphometer

Secondary outcomes

  1. Muscle strength

    Time frame: 2-4 minutes

    Assessed by sit-to-stand test

  2. Mobility

    Time frame: 16-20 minutes

    Assessed by 6-minute walking test

  3. Bone and muscle properties and estimated bone strength of the lower leg and forearm

    Time frame: 20-30 minutes

    Assessed by peripheral quantitative computed tomography (pQCT)

  4. Total body lean tissue mass (g)

    Time frame: 10-20 minutes

    Assessed by dual-energy X-ray absorptiometry (DXA)

  5. Proximal femur bone mineral density (g/cm^2)

    Time frame: 10-20 minutes

    Assessed by dual-energy X-ray absorptiometry (DXA)

  6. Kyphosis angle

    Time frame: 3-5 minutes

    Assessed by flexicurve

  7. Physical activity exercise confidence

    Time frame: 2-5 minutes

    Assessed 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.

  8. Fear of falling

    Time frame: 2-5 minutes

    Assessed 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.

  9. Physical activity

    Time frame: 7 days

    Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Royal University Hospital Foundation
  • Saskatchewan Centre for Patient-Oriented Research
  • Saskatchewan Health Research Foundation

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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