Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
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|ClinicalTrials.gov Identifier: NCT03885466|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Hyperkyphosis Vertebral Fracture||Behavioral: Nordic Walking exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|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.|
|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|
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
- 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
- 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
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
|Contact: Saija Kontulainen, PhDfirstname.lastname@example.org|
|Contact: Anthony D Kehrig, MScemail@example.com|
|Principal Investigator:||Saija Kontulainen, PhD||University of Saskatchewan|