Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

NCT03885466 | Completed

• 1 other identifier: 140
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Hyperkyphosis; Vertebral Fracture

Keywords

Nordic walking; Osteoporosis; Hyperkyphosis; Vertebral Fracture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Muscle strength

  2-4 minutes

• Mobility

  16-20 minutes

• Bone and muscle properties and estimated bone strength of the lower leg and forearm

  20-30 minutes

• Total body lean tissue mass (g)

  10-20 minutes

• Proximal femur bone mineral density (g/cm^2)

  10-20 minutes

Study Arms (2)

Nordic walking

EXPERIMENTAL

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

Behavioral: Nordic Walking exercise

Control

NO INTERVENTION

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

Interventions

Nordic Walking exercise BEHAVIORAL

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.

Nordic walking

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Royal University Hospital Foundation: collaborator
• Saskatchewan Health Research Foundation: collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Links

• Study website

MeSH Terms

Conditions

Osteoporosis; Kyphosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Saija Kontulainen, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 21, 2019
• Study Start: October 18, 2019
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)