Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2021

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

  • Behavioral: Nordic Walking exercise
    • 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.

Arms, Groups and Cohorts

  • Experimental: Nordic walking
    • Nordic walking exercise intervention, 3 times per week over 12 weeks
  • No Intervention: Control
    • Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements

Clinical Trial Outcome Measures

Primary Measures

  • Functional balance
    • Time Frame: 3-5 minutes
    • Assessed by timed up and go test (TUG)
  • 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.
  • Kyphosis angle
    • Time Frame: 2-3 minutes
    • Assessed using kyphometer

Secondary Measures

  • Muscle strength
    • Time Frame: 2-4 minutes
    • Assessed by sit-to-stand test
  • Mobility
    • Time Frame: 16-20 minutes
    • Assessed by 6-minute walking test
  • 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)
  • Total body lean tissue mass (g)
    • Time Frame: 10-20 minutes
    • Assessed by dual-energy X-ray absorptiometry (DXA)
  • Proximal femur bone mineral density (g/cm^2)
    • Time Frame: 10-20 minutes
    • Assessed by dual-energy X-ray absorptiometry (DXA)
  • Kyphosis angle
    • Time Frame: 3-5 minutes
    • Assessed by flexicurve
  • 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.
  • 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.
  • Physical activity
    • Time Frame: 7 days
    • Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Saskatchewan
  • Collaborator
    • Royal University Hospital Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Saija Kontulainen, Professor – University of Saskatchewan
  • Overall Official(s)
    • Saija Kontulainen, PhD, Principal Investigator, University of Saskatchewan
  • Overall Contact(s)
    • Saija Kontulainen, PhD, 3069661077, saija.kontulainen@usask.ca

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