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Risk of FallingNCT05965011

Nordic Walking to Manage Falls and Fear of Falling

A study testing Exercise training in people with Risk of Falling, run by Dr. Mohammad Auais, PhD at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Risk of Falling
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteCanada
Study dates
29 Aug 2022to 30 Nov 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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be 60+ years old.
  • Be at risk of falling, as determined by the Stay Independent Falls Risk Assessment Tool. This validated tool is recommended by the STEADI fall prevention program to evaluate risk of falling.

Who cannot join

  • Inability to use walking poles due to medical conditions.
  • Inability to walk 400m independently.
  • Having a medical condition such as unstable cardiorespiratory status, impending angioplasty, or ataxia/dyskinesia (unsteady, staggering gait) that prevents them from participating in physical activities or using walking poles is prohibited.
  • Taking part in any other structured exercise program.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • School of Rehabilitation Therapy, Queens University

    Kingston, Ontario

Other trials in Canada

About this study

Official title: Walking on 'Four Legs' to Manage Falls and Fear of Falling

This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Participants will be asked to:

Read more
  • Attend training sessions to learn proper Nordic Walking techniques.
  • Engage in supervised Nordic Walking sessions for a specified duration and frequency.
  • Keep a log of their walking activities and any falls or near falls experienced.
  • Complete questionnaires to assess their fear of falling and overall physical activity levels.

If there is a comparison group:

Researchers will compare the intervention group, consisting of older adults participating in the Nordic Walking program, with a control group of older adults who do not receive the intervention. The comparison will be made to determine if Nordic Walking has a significant impact on reducing falls and fear of falling compared to the control group.

Read the detailed description

Introduction:

this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Background:

Falls and fear of falling are significant concerns among older adults, leading to physical impairments, psychological trauma, and a decline in abilities and quality of life. Exercise has been shown to be effective in improving muscle strength, balance, mobility, and postural control, all of which are risk factors for falls and FOF. However, traditional exercise programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic Walking, a low-risk and low-tech intervention, has emerged as a promising alternative, offering numerous physical and mental health benefits.

Study Design:

The study will be conducted in two stages. Stage One will involve a two-arm, parallel, single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will be recruited and randomly assigned to either a 10-week NW intervention group or a control group. The intervention group will receive supervised NW training sessions and will be coached to practice independently. The control group will receive regular phone calls to discuss healthy lifestyle habits.

Outcome Measures:

The study will collect feasibility and safety data, including recruitment, adherence, and follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool, Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and the Four-Square Step Test (FSST).

Data Analysis:

Descriptive statistics will be used to characterize participants and feasibility measures. Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests and chi-square tests will be used to compare the intervention and control groups. The main focus of the analysis will be to estimate the effect size, test the intervention's feasibility and safety, and inform future studies.

Sample Size:

The study aims to recruit 40 participants (20 per group) to ensure study robustness and account for potential dropouts.

Stage Two:

In the second stage, qualitative interviews will be conducted with all participants in the intervention group to gather feedback on the acceptability, perceived value, barriers, and facilitators of participating. The data will be analyzed using interpretive description to identify themes and categories.

Conditions
Risk of Falling
Being tested
Exercise training
Keywords
Fear of Falling, Nordic Walking, Older adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingOther

    Also called Nordic walking

    The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.

Study groups in NCT05965011
Study groupRoleWhat they receive
Intervention (Nordic walking)ExperimentalNordic walking training. These coaching principles will focus on highlighting the participants' strengths and resourcefulness, setting goals, and utilizing solution-focused problem-solving techniques to achieve those goals during practice and related activities . This group sessions will be conducted biweekly to ensure appropriate progression and adherence to the guidelines set by the International Nordic Walking Federation. In addition to the supervised group sessions, participants will also receive supervised NW training from a certified NW instructor. Participants will be encouraged to set goals and develop strategies to facilitate independent practice for at least three 30-minute sessions per week over a period of 10 weeks. These unsupervised sessions aim to encourage participants to engage in regular practice outside of the group sessions.
Receives: Other: Exercise training
Control (phone calls)No interventionThe control group will receive regular contact to control for attention and maintain participant engagement throughout the study. Over the course of the 10 weeks, participants in this group will receive 5 biweekly phone calls from the study's graduate research assistant (RA). During each phone call, the RA will engage in discussions with participants about leading a healthy lifestyle in general, covering topics such as proper nutrition and adequate sleep. Additionally, the RA will gather safety-related data, including information on any falls that may have occurred. The phone calls will also serve as reminders for participants about upcoming assessments and their importance in the study. The investigators will provide a training session to the control group following the completion of the study if they are interested.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the effect size of intervention (Cohen's D)

    Effect size estimation is vital in assessing the impact of interventions like Nordic walking and planning future studies. It involves quantifying the magnitude of the intervention's effect on the outcome variable.

    Measured: Through study completion, an average of 1.5 years

  2. Evaluate the adherence rate to the intervention (as a measure of feasibility)

    Participant Adherence to the Intervention: This measure examines the extent to which participants adhere to the prescribed Nordic walking program. It involves tracking the frequency, duration, and intensity of Nordic walking sessions completed by participants. Adherence rates can be calculated based on the number of sessions attended or completed as planned.

    Measured: Through study completion, an average of 1.5 years

  3. Assess safety of the intervention

    Monitoring Adverse Events: We systematically record and monitor any adverse events or incidents during the study. This includes injuries, discomfort, or any negative effects reported by participants.

    Measured: Through study completion, an average of 1.5 years

Secondary outcomes (3)
  1. Timed Up and Go (TUG) to assess fall risk

    The Timed Up and Go (TUG) test is a widely used clinical assessment tool to evaluate mobility and functional mobility, specifically in older adults. While it is not specifically designed to determine the risk of falling, it can provide valuable information that is correlated with fall risk. The TUG test measures the time it takes for an individual to stand up from a chair, walk a set distance (typically 3 meters), turn around, return to the chair, and sit down again.

    Measured: Pre (week 0) /post intervention (week 11)

  2. Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)

    Scale: Falls Efficacy Scale-International (FES-I) Minimum Value: 0 (not at all confident) Maximum Value: 100 (completely confident) Interpretation: In the FES-I, higher scores indicate greater fear of falling. Therefore, a higher score on the FES-I reflects a worse outcome, indicating a higher level of fear and reduced confidence in performing daily activities without falling. Conversely, a lower score on the FES-I suggests a better outcome, indicating a lower level of fear and greater confidence in performing activities without fear of falling.

    Measured: Pre (week 0) /post intervention (week 11)

  3. Performance on the Four-Square Step Test (FSST) will be measured to assess balance.

    The Four-Square Step Test (FSST) does not yield a specific score on a scale like some other assessments. Instead, the FSST primarily focuses on the time taken to complete the test and the occurrence of errors or missteps.

    When assessing FSST performance, the following information is typically recorded:

    Completion Time: The time the individual takes to complete the FSST is measured in seconds. A shorter completion time generally indicates better balance and agility.

    Errors or Missteps: The number of errors or missteps made by the individual during the FSST is recorded. Errors can include stepping outside the designated squares, incorrect foot placement, or loss of balance. Fewer errors suggest better balance control and coordination.

    Measured: Pre (week 0) /post intervention (week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start29 Aug 2022
  3. Primary completion15 Oct 2023
  4. Study completion30 Nov 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05965011
Sponsor's protocol ID
6030812
Status last verified
Dec 2023
First submitted
15 Jun 2023
Last updated
13 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. doi: 10.1093/gerona/56.5.b209.

    PubMed 11320101
  • Krasovsky T, Banina MC, Hacmon R, Feldman AG, Lamontagne A, Levin MF. Stability of gait and interlimb coordination in older adults. J Neurophysiol. 2012 May;107(9):2560-9. doi: 10.1152/jn.00950.2011. Epub 2012 Feb 1.

    PubMed 22298827
  • Herman T, Giladi N, Gurevich T, Hausdorff JM. Gait instability and fractal dynamics of older adults with a "cautious" gait: why do certain older adults walk fearfully? Gait Posture. 2005 Feb;21(2):178-85. doi: 10.1016/j.gaitpost.2004.01.014.

    PubMed 15639397
  • Beauchet O, Annweiler C, Allali G, Berrut G, Herrmann FR, Dubost V. Recurrent falls and dual task-related decrease in walking speed: is there a relationship? J Am Geriatr Soc. 2008 Jul;56(7):1265-9. doi: 10.1111/j.1532-5415.2008.01766.x. Epub 2008 May 26.

    PubMed 18510582
  • Bertera EM, Bertera RL. Fear of falling and activity avoidance in a national sample of older adults in the United States. Health Soc Work. 2008 Feb;33(1):54-62. doi: 10.1093/hsw/33.1.54.

    PubMed 18326450
  • Keast M-L. Nordic walking: introducing a new low-impact exercise system for cardiac rehabilitation patients. Minto prevention and rehabilitation center, University of Ottawa Heart Institute. 2009:13- 14.

  • Ossowski Z, Wawryniku M, Česnaitiene V. Influence of nordic walking training on static and dynamic body balance among the elderly. Baltic Journal of Health and Physical Activity. 2015;7(1):72-80.

  • Karawan A, Porcari J, Butta H, Postmus A, Stoughton L, Larkin J. Effects of 12 weeks of walking or exerstriding on upper body strength and endurance. Medicine & Science in Sports & Exercise. 1992;24(5):S138.

  • Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.

    PubMed 28229255
  • Dalton C, Nantel J. Nordic Walking Improves Postural Alignment and Leads to a More Normal Gait Pattern Following Weeks of Training: A Pilot Study. J Aging Phys Act. 2016 Oct;24(4):575-582. doi: 10.1123/japa.2015-0204. Epub 2016 Aug 24.

    PubMed 27051072
  • Willson J, Torry MR, Decker MJ, Kernozek T, Steadman JR. Effects of walking poles on lower extremity gait mechanics. Med Sci Sports Exerc. 2001 Jan;33(1):142-7. doi: 10.1097/00005768-200101000-00021.

    PubMed 11194099
  • Reelick MF, van Iersel MB, Kessels RP, Rikkert MG. The influence of fear of falling on gait and balance in older people. Age Ageing. 2009 Jul;38(4):435-40. doi: 10.1093/ageing/afp066. Epub 2009 May 18.

    PubMed 19451658
  • Rubenstein LZ, Vivrette R, Harker JO, Stevens JA, Kramer BJ. Validating an evidence-based, self-rated fall risk questionnaire (FRQ) for older adults. J Safety Res. 2011 Dec;42(6):493-9. doi: 10.1016/j.jsr.2011.08.006. Epub 2011 Nov 17.

    PubMed 22152267
  • Stevens JA. The STEADI Tool Kit: A Fall Prevention Resource for Health Care Providers. IHS Prim Care Provid. 2013 Sep;39(9):162-166. No abstract available.

    PubMed 26766893
  • van Zyl LE, Roll LC, Stander MW, Richter S. Positive Psychological Coaching Definitions and Models: A Systematic Literature Review. Front Psychol. 2020 May 6;11:793. doi: 10.3389/fpsyg.2020.00793. eCollection 2020.

    PubMed 32435218

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Risk of Falling, run by Dr. Mohammad Auais, PhD at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2023. 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?

Estimate the effect size of intervention (Cohen's D) (time frame: Through study completion, an average of 1.5 years). 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?

On the ClinicalTrials.gov record for NCT05965011, which also lists 76 linked publications.

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 13 Dec 2023.

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