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Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885466
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Royal University Hospital Foundation
Saskatchewan Health Research Foundation
Saskatchewan Centre for Patient-Oriented Research
Information provided by (Responsible Party):
Saija Kontulainen, University of Saskatchewan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Hyperkyphosis Vertebral Fracture Behavioral: Nordic Walking exercise Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Treatment
Official Title: Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nordic walking
Nordic walking exercise intervention, 3 times per week over 12 weeks
 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.
No Intervention: Control
Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885466


Contacts
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Contact: Saija Kontulainen, PhD 3069661077 saija.kontulainen@usask.ca
Contact: Anthony D Kehrig, MSc 3069661096 anthony.kehrig@usask.ca

Locations
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Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 5B2
Contact: Saija Kontulainen, PhD    3069661077    saija.kontulainen@usask.ca   
Contact: Anthony Kehrig    3069661096    nordic.walking.study@usask.ca   
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
Saskatchewan Health Research Foundation
Saskatchewan Centre for Patient-Oriented Research
Investigators
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Principal Investigator: Saija Kontulainen, PhD University of Saskatchewan
More Information
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Publications:

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Responsible Party: Saija Kontulainen, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03885466    
Other Study ID Numbers: 140
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Saija Kontulainen, University of Saskatchewan:
Nordic walking
Osteoporosis
Hyperkyphosis
Vertebral Fracture
Additional relevant MeSH terms:
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Osteoporosis
Kyphosis
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
 Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries
Spinal Curvatures
Spinal Diseases