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Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Primary Purpose

Osteoporosis, Hyperkyphosis, Vertebral Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nordic Walking exercise
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Nordic walking, Osteoporosis, Hyperkyphosis, Vertebral Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of SaskatchewanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nordic walking

Control

Arm Description

Nordic walking exercise intervention, 3 times per week over 12 weeks

Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements

Outcomes

Primary Outcome Measures

Functional balance
Assessed by timed up and go test (TUG)
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.
Kyphosis angle
Assessed using kyphometer

Secondary Outcome Measures

Muscle strength
Assessed by sit-to-stand test
Mobility
Assessed by 6-minute walking test
Bone and muscle properties and estimated bone strength of the lower leg and forearm
Assessed by peripheral quantitative computed tomography (pQCT)
Total body lean tissue mass (g)
Assessed by dual-energy X-ray absorptiometry (DXA)
Proximal femur bone mineral density (g/cm^2)
Assessed by dual-energy X-ray absorptiometry (DXA)
Kyphosis angle
Assessed by flexicurve
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.
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.
Physical activity
Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring

Full Information

First Posted
February 21, 2019
Last Updated
May 8, 2023
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
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1. Study Identification

Unique Protocol Identification Number
NCT03885466
Brief Title
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Official Title
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Hyperkyphosis, Vertebral Fracture
Keywords
Nordic walking, Osteoporosis, Hyperkyphosis, Vertebral Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nordic walking
Arm Type
Experimental
Arm Description
Nordic walking exercise intervention, 3 times per week over 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking exercise
Intervention Description
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 Outcome Measure Information:
Title
Functional balance
Description
Assessed by timed up and go test (TUG)
Time Frame
3-5 minutes
Title
Quality of life score
Description
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.
Time Frame
5-10 minutes
Title
Kyphosis angle
Description
Assessed using kyphometer
Time Frame
2-3 minutes
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Assessed by sit-to-stand test
Time Frame
2-4 minutes
Title
Mobility
Description
Assessed by 6-minute walking test
Time Frame
16-20 minutes
Title
Bone and muscle properties and estimated bone strength of the lower leg and forearm
Description
Assessed by peripheral quantitative computed tomography (pQCT)
Time Frame
20-30 minutes
Title
Total body lean tissue mass (g)
Description
Assessed by dual-energy X-ray absorptiometry (DXA)
Time Frame
10-20 minutes
Title
Proximal femur bone mineral density (g/cm^2)
Description
Assessed by dual-energy X-ray absorptiometry (DXA)
Time Frame
10-20 minutes
Title
Kyphosis angle
Description
Assessed by flexicurve
Time Frame
3-5 minutes
Title
Physical activity exercise confidence
Description
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.
Time Frame
2-5 minutes
Title
Fear of falling
Description
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.
Time Frame
2-5 minutes
Title
Physical activity
Description
Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring
Time Frame
7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saija Kontulainen, PhD
Phone
3069661077
Email
saija.kontulainen@usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mahdi Rostami, PhD
Phone
3069661096
Email
mahdi.rostami@usask.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saija Kontulainen, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saija Kontulainen, PhD
Phone
3069661077
Email
saija.kontulainen@usask.ca
First Name & Middle Initial & Last Name & Degree
Mahdi Rostami, PhD
Phone
3069661096
Email
nordic.walking.study@usask.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://research-groupstest.usask.ca/nws/index.php
Description
Study website

Learn more about this trial

Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

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