Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Osteoporosis Clinical Trial

Official title:

Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885466
• Other study ID #: 140
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: December 21, 2023

Study information

• Verified date: February 2024
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hyperkyphosis
• Kyphosis
• Osteoporosis
• Spinal Fractures
• Vertebral Fracture

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
University of Saskatchewan	Royal University Hospital Foundation, Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional balance	Assessed by timed up and go test (TUG)	3-5 minutes
Primary	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
Primary	Kyphosis angle	Assessed using kyphometer	2-3 minutes
Secondary	Muscle strength	Assessed by sit-to-stand test	2-4 minutes
Secondary	Mobility	Assessed by 6-minute walking test	16-20 minutes
Secondary	Bone and muscle properties and estimated bone strength of the lower leg and forearm	Assessed by peripheral quantitative computed tomography (pQCT)	20-30 minutes
Secondary	Total body lean tissue mass (g)	Assessed by dual-energy X-ray absorptiometry (DXA)	10-20 minutes
Secondary	Proximal femur bone mineral density (g/cm^2)	Assessed by dual-energy X-ray absorptiometry (DXA)	10-20 minutes
Secondary	Kyphosis angle	Assessed by flexicurve	3-5 minutes
Secondary	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
Secondary	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
Secondary	Physical activity	Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring	7 days

External Links

•   Study website