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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Vertebral Fracture; Hyperkyphosis
• Intervention / Treatment: Behavioral: Nordic Walking exercise

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5B2
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional balance	Assessed by timed up and go test (TUG)	3-5 minutes
Quality of life score	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.	5-10 minutes
Kyphosis angle	Assessed using kyphometer	2-3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling	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.	2-5 minutes
Muscle strength	Assessed by sit-to-stand test	2-4 minutes
Mobility	Assessed by 6-minute walking test	16-20 minutes
Bone and muscle properties and estimated bone strength of the lower leg and forearm	Assessed by peripheral quantitative computed tomography (pQCT)	20-30 minutes
Total body lean tissue mass (g)	Assessed by dual-energy X-ray absorptiometry (DXA)	10-20 minutes
Proximal femur bone mineral density (g/cm^2)	Assessed by dual-energy X-ray absorptiometry (DXA)	10-20 minutes
Kyphosis angle	Assessed by flexicurve	3-5 minutes
Physical activity exercise confidence	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.	2-5 minutes
Physical activity	Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring	7 days

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Health Research Foundation; Royal University Hospital Foundation; Saskatchewan Centre for Patient-Oriented Research
• Investigators: Principal Investigator: Saija Kontulainen, PhD, University of Saskatchewan

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Osteoporosis; Nordic walking; Vertebral Fracture; Hyperkyphosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Fractures, Bone; Osteoporosis; Spinal Fractures; Kyphosis
• Other Study ID Numbers: 140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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