OsteoporosisNCT03885466
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
A study testing Nordic Walking exercise in people with Osteoporosis and Hyperkyphosis, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Hyperkyphosis, Vertebral Fracture
- What is being tested?
- Nordic Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2019to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoporosis, Hyperkyphosis, Vertebral Fracture
- Being tested
- Nordic Walking exercise
- Keywords
- Nordic walking, Osteoporosis, Hyperkyphosis, Vertebral Fracture
- Medical subject headings
- Osteoporosis, Kyphosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic Walking exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nordic walking | Experimental | Nordic walking exercise intervention, 3 times per week over 12 weeks Receives: Behavioral: Nordic Walking exercise |
| Control | No intervention | Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional balance
Assessed by timed up and go test (TUG)
Measured: 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.
Measured: 5-10 minutes
Kyphosis angle
Assessed using kyphometer
Measured: 2-3 minutes
Secondary outcomes (9)
Muscle strength
Assessed by sit-to-stand test
Measured: 2-4 minutes
Mobility
Assessed by 6-minute walking test
Measured: 16-20 minutes
Bone and muscle properties and estimated bone strength of the lower leg and forearm
Assessed by peripheral quantitative computed tomography (pQCT)
Measured: 20-30 minutes
Total body lean tissue mass (g)
Assessed by dual-energy X-ray absorptiometry (DXA)
Measured: 10-20 minutes
Proximal femur bone mineral density (g/cm^2)
Assessed by dual-energy X-ray absorptiometry (DXA)
Measured: 10-20 minutes
Kyphosis angle
Assessed by flexicurve
Measured: 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.
Measured: 2-5 minutes
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.
Measured: 2-5 minutes
Physical activity
Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start18 Oct 2019
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Royal University Hospital Foundation, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Responsible party
- Principal investigator, Saija Kontulainen, University of Saskatchewan
- Investigators
- Saija Kontulainen, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885466
- Sponsor's protocol ID
- 140
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
- ClinicalTrials.gov ID
- NCT03885466
- Acronym / sponsor ID
- 140
- Conditions
- Osteoporosis, Hyperkyphosis, Vertebral Fracture
- Keywords
- Nordic walking, Osteoporosis, Hyperkyphosis, Vertebral Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Royal University Hospital Foundation, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nordic walking | Experimental | Behavioral: Nordic Walking exerciseNordic walking exercise intervention, 3 times per week over 12 weeks |
| Control | No intervention | –Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic Walking exerciseParticipants 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. | Behavioural | Nordic walking |
Primary outcome
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
9 secondary outcomes
Muscle strength
Time frame: 2-4 minutes
Mobility
Time frame: 16-20 minutes
Bone and muscle properties and estimated bone strength of the lower leg and forearm
Time frame: 20-30 minutes
Total body lean tissue mass (g)
Time frame: 10-20 minutes
Proximal femur bone mineral density (g/cm^2)
Time frame: 10-20 minutes
Kyphosis angle
Time frame: 3-5 minutes
Physical activity exercise confidence
Time frame: 2-5 minutes
Fear of falling
Time frame: 2-5 minutes
Physical activity
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saija Kontulainen, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic Walking exercise in people with Osteoporosis and Hyperkyphosis, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional balance (time frame: 3-5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.