NCT06404216

Brief Summary

Abstract: The purpose of this pilot study is to examine the effect and feasibility of a Nordic walking group training intervention on the physical and mental health of older adults evacuated from their homes to Haifa. Participants: The study will include 31 participants aged 65 and over who are in stable health and have been cleared by their physician to participate in this NW program. Intervention: The intervention will consist of two 60-minute Nordic walking (NW) sessions per week for two months, 16 sessions in total. Participants will be provided with walking sticks to use during the sessions. The sessions will be led by certified health professionals (PT, RN), assisted by trained undergraduate and graduate physiotherapy students. Outcomes: The primary outcome will be endurance to the walking sessions, and average weekly and monthly number of steps, measured by a smartphone application. Secondary outcomes will include three physical tests: 30-second sit-to-stand test, 4-meter walk test and heel raise test. mental health (PHQ-9 depression scale, GAD-7 anxiety scale, WHOQOL- BREF quality of life scale, PANAS short form positive and negative affect scale), and perceived global effect of the intervention. Design: The study will use a single-group pre-test/post-test design. Participants will be assessed at baseline, after two months of intervention, and at six months follow-up. Data Analysis: Data will be analyzed using descriptive statistics and mixed-effects linear regression models. Significance: This pilot study will provide valuable information on the feasibility and effect of this group NW intervention for older adults evacuated from their homes. The findings will be used to plan and design a larger longitudinal RCT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 7, 2026

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

April 22, 2024

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Steps count by a smartphone application.

    weakly and monthly average of steps count will be retrieved from the cellular application.

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • Adherence (number of patients that attended training sessions during the intervention time and throughout 4 months post intervention)

    Adherence to the walking program: participation in the 16 trained sessions during the intervention, and adherence to 150min/week during follow up period of 4 months post intervention. Optimal adherence outcome will be up to 20% absence.

    participation will be monitored during the 8 weeks of intervention. Follow up evaluation of independent walking throughout 4 months after intervention completion.

Secondary Outcomes (8)

  • 30 seconds Sit to stand test (number of repetitions for measuring lower limb strength and balance)

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • Two-minute walk test ( distance in meters for measuring functional endurance and gait performance)

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • Patient Health Questionnaire (score in depression questionnaire to assess the risk of developing mental health problems)

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • Generalized Anxiety Disorder (score in anxiety questionnaire to assess the risk of developing mental health problems)

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • The World Health Organization quality of life assessment (score in the questionnaire to assess quality of life)

    Baseline; immediately after intervention completion (week 8); 2,4 months post intervention follow-up.

  • +3 more secondary outcomes

Study Arms (1)

Nordic walking group training

EXPERIMENTAL

The intervention will consist of 60-minute NW group sessions, twice weekly, for two months (total 16 sessions). Participants will be provided with NW sticks to use during the sessions. Each session will be led by a qualified healthcare professional that received 4 hours NW guidance qualification, and participated in 4 sessions prior to leading one. Current qualified healthcare professionals are 2 physiotherapists, and a certified nurse. Final year physiotherapy students will assist, hence each session will be guided by two members of the research team- a clinician and a student. A social worker will participate in one weekly session aiming to empower the participants and utilize group dynamics techniques to promote successful continuation of independent walking following the guided period.

Other: Nordic walking group training

Interventions

16 60-minute NW group sessions, twice weekly. Sessions will be led by a qualified healthcare professional and a graduating student. A social worker (SP) will participate in one weekly session aiming to empower the participants and utilize group dynamics techniques to promote successful continuation of independent walking following the guided period. Communication throughout the study will be conducted via a WhatsApp forum, to motivate and sustain regular walking during and after the training period. Following 2 months of guidance the group will be launched independently, while keeping remote contact. Same frequency and schedule will be encouraged.

Nordic walking group training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants in stable health and have been cleared by their doctor to participate in physical activity.

You may not qualify if:

  • Using an assisting device for walking
  • Any health condition that may prevent participants from doing physical activity according to their medical doctor.
  • Unstable gait with high risk of fall by subjective and physical assessment,
  • Dizziness, visual or hearing impairment that cannot be corrected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dan Carmel Hotel

Haifa, 34642, Israel

Location

Related Publications (24)

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    PMID: 34820657BACKGROUND
  • Ding D, Mutrie N, Bauman A, Pratt M, Hallal PRC, Powell KE. Physical activity guidelines 2020: comprehensive and inclusive recommendations to activate populations. Lancet. 2020 Dec 5;396(10265):1780-1782. doi: 10.1016/S0140-6736(20)32229-7. Epub 2020 Nov 25. No abstract available.

    PMID: 33248019BACKGROUND
  • The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k.

    PMID: 8560308BACKGROUND
  • Phraknoi N, Sutanto J, Hu Y, Goh YS, Lee CEC. Older people's needs in urban disaster response: A systematic literature review. International Journal of Disaster Risk Reduction. 2023:103809.

    BACKGROUND
  • Ben Simon B, Toporek Barr O, Kermel-Schiffman I, Sorek Y, Resnizky S, Jacobovitz Y. The Israel-Hamas War - The Impact of Loss and Bereavement on Families and the Community: A Litererature Review. In: Shani M, ed. Jerusalem, Israel: Myers JDC Brookdale Institute; 2023.

    BACKGROUND
  • Swanson CW, Haigh ZJ, Fling BW. Two-minute walk tests demonstrate similar age-related gait differences as a six-minute walk test. Gait Posture. 2019 Mar;69:36-39. doi: 10.1016/j.gaitpost.2019.01.019. Epub 2019 Jan 14.

    PMID: 30660949BACKGROUND
  • Bohannon RW, Wang YC, Gershon RC. Two-minute walk test performance by adults 18 to 85 years: normative values, reliability, and responsiveness. Arch Phys Med Rehabil. 2015 Mar;96(3):472-7. doi: 10.1016/j.apmr.2014.10.006. Epub 2014 Oct 25.

    PMID: 25450135BACKGROUND
  • Cunningham C, O' Sullivan R, Caserotti P, Tully MA. Consequences of physical inactivity in older adults: A systematic review of reviews and meta-analyses. Scand J Med Sci Sports. 2020 May;30(5):816-827. doi: 10.1111/sms.13616. Epub 2020 Feb 4.

  • Wang Z, Jiang B, Wang X, Li Z, Wang D, Xue H, Wang D. Relationship between physical activity and individual mental health after traumatic events: a systematic review. Eur J Psychotraumatol. 2023;14(2):2205667. doi: 10.1080/20008066.2023.2205667.

  • Russo L, Belli G, Di Blasio A, Lupu E, Larion A, Fischetti F, Montagnani E, Di Biase Arrivabene P, De Angelis M. The Impact of Nordic Walking Pole Length on Gait Kinematic Parameters. J Funct Morphol Kinesiol. 2023 Apr 26;8(2):50. doi: 10.3390/jfmk8020050.

  • Skorkowska-Telichowska K, Kropielnicka K, Bulinska K, Pilch U, Wozniewski M, Szuba A, Jasinski R. Nordic walking in the second half of life. Aging Clin Exp Res. 2016 Dec;28(6):1035-1046. doi: 10.1007/s40520-016-0531-8. Epub 2016 Jan 23.

  • Bieler T, Siersma V, Magnusson SP, Kjaer M, Christensen HE, Beyer N. In hip osteoarthritis, Nordic Walking is superior to strength training and home-based exercise for improving function. Scand J Med Sci Sports. 2017 Aug;27(8):873-886. doi: 10.1111/sms.12694. Epub 2016 Apr 30.

  • Liu Y, Xie W, Li J, Ossowski Z. Effects of aerobic exercise on metabolic indicators and physical performance in adult NAFLD patients: A systematic review and network meta-analysis. Medicine (Baltimore). 2023 Apr 7;102(14):e33147. doi: 10.1097/MD.0000000000033147.

  • Gobbo S, Bullo V, Roma E, Duregon F, Bocalini DS, Rica RL, Di Blasio A, Cugusi L, Vendramin B, Bergamo M, Cruz-Diaz D, Alberton CL, Ermolao A, Bergamin M. Nordic Walking Promoted Weight Loss in Overweight and Obese People: A Systematic Review for Future Exercise Prescription. J Funct Morphol Kinesiol. 2019 Jun 18;4(2):36. doi: 10.3390/jfmk4020036.

  • Rodrigues IB, Ponzano M, Butt DA, Bartley J, Bardai Z, Ashe MC, Chilibeck PD, Thabane L, Wark JD, Stapleton J, Giangregorio LM. The Effects of Walking or Nordic Walking in Adults 50 Years and Older at Elevated Risk of Fractures: A Systematic Review and Meta-Analysis. J Aging Phys Act. 2021 Oct 1;29(5):886-899. doi: 10.1123/japa.2020-0262. Epub 2021 Feb 11.

  • Kyrdalen IL, Thingstad P, Sandvik L, Ormstad H. Associations between gait speed and well-known fall risk factors among community-dwelling older adults. Physiother Res Int. 2019 Jan;24(1):e1743. doi: 10.1002/pri.1743. Epub 2018 Sep 10.

  • Roongbenjawan N, Siriphorn A. Accuracy of modified 30-s chair-stand test for predicting falls in older adults. Ann Phys Rehabil Med. 2020 Jul;63(4):309-315. doi: 10.1016/j.rehab.2019.08.003. Epub 2019 Sep 11.

  • Bohannon RW. The heel-raise test for ankle plantarflexor strength: a scoping review and meta-analysis of studies providing norms. J Phys Ther Sci. 2022 Jul;34(7):528-531. doi: 10.1589/jpts.34.528. Epub 2022 Jul 1.

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  • Gagliardi J, Brettschneider C, Konig HH. Health-related quality of life of refugees: a systematic review of studies using the WHOQOL-Bref instrument in general and clinical refugee populations in the community setting. Confl Health. 2021 Jun 2;15(1):44. doi: 10.1186/s13031-021-00378-1.

  • Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010 Jul;63(7):760-766.e1. doi: 10.1016/j.jclinepi.2009.09.009. Epub 2010 Jan 8.

  • Liu Y, Xie W, Ossowski Z. The effects of Nordic Walking on health in adults: A systematic review. Journal of Education, Health and Sport. 2023;13:188-196.

    RESULT

MeSH Terms

Conditions

War-Related Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Hilla Sarig-Bahat, Phd

    University of Haifa, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The assessor will be external, not part of the training team, to avoid bias due to trainer/therapist- training participant subjective biases. Therefore there is assessor blinding but not to allocation as there is one arm.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One arm of treatment in a special displaced population during war. This is a pilot feasibility study, prior to a full RCT in order to evaluate this protocol. Intervention of 2 weekly sessions for 8 weeks (total 16). Assessments will be conducted by a blinded assessor at baseline, end of training, 2+4 months post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 22, 2024

First Posted

May 8, 2024

Study Start

May 16, 2024

Primary Completion

July 16, 2025

Study Completion

December 1, 2025

Last Updated

January 7, 2026

Record last verified: 2024-06

Locations