NCT06684574

Brief Summary

The goal of this randomized clinical trial is to improve osteoarthritis symptoms and quality of life in older people with knee osteoarthritis from a primary care center. The main question it aims to answer is:

  • To participate in a Nordic walking reduces pain measured on WOMAC pain dimension?
  • To participate in a Nordic walking improves mobility measured on WOMAC physical activitiy dimension? Researchers will compare pain and physical activity outcomes between intervention and control arm (randomly allocated).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

Study Start

First participant enrolled

February 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

November 8, 2024

Last Update Submit

November 9, 2024

Conditions

Osteoarthritis of Knee

Keywords

Knee osteoarthritisQuality of lifeCovid-19Exercise therapyNordic walking

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items) and physical function. WOMAC is available and validated in Spanish language. Overall, the sum of the three dimensions can have a minimum of zero points and a maximum of 96 points where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.

    From enrollment to the end of treatment at 10 weeks

Secondary Outcomes (1)

  • 36-Item Short Form Survey Instrument (SF-36)

    From enrollment to the end of treatment at 10 weeks

Other Outcomes (3)

  • Time up and go

    From enrollment to the end of treatment at 10 weeks

  • Sit to stand

    From enrollment to the end of treatment at 10 weeks

  • 6-minute walk test

    From enrollment to the end of treatment at 10 weeks

Study Arms (2)

Nordic walking program

ACTIVE COMPARATOR

Patients randomly allocated this arm participated in a nordic walking program to improve their pain symptoms and quality of life

Other: Nordic walking program

Control group

PLACEBO COMPARATOR

Patients randomly assigned to this group received only one educational session to advice the convenience of exercising on their own initiative.

Other: Educational advise

Interventions

Nordic walking programOTHER

The intervention is a defined program of Nordic walking and strengthening exercises for 10 weeks in a regimen of two days per week (two 75-minute sessions per week). In these sessions, they did Nordic walking three 5-minute breaks, where strength and proprioception exercises of the lower extremities were performed.

Nordic walking program
Educational adviseOTHER

Patients in the control arm participated in a single session to advise them on the need for self-exercise.

Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged of 60 years or older
  • Knee osteoarthritis
  • Body mass index less than 35 kg/m2

You may not qualify if:

  • People who had a knee prostheses
  • To have any contraindication for physical activity
  • To have an acute exacerbation of any chronic condition at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and Welfare Sciences School

Vic, Barcelona, 08500, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, KneeCOVID-19

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pere Roura-Poch, PhD

    Vic Hospital Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention is a program of nordic walking and strengtheining exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Philosophy doctor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

February 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The principal investigator will provide participant data if a justified request is received.

Shared Documents
CSR
Time Frame
5 years after completion
Access Criteria
Adressing a letter with objectives and a justification about data needed

Locations

ES(1)