NCT03722277

Brief Summary

This is a randomized controlled trial investigating the effect of variable load training in patients with knee osteoarthrosis. The intervention will consist of resistance training with variable load in knee extension- and flexion. The control group will receive conventional strength training with rubber band. Outcome measures will be the Knee Osteoarthrosis Outcome Score, functional capacity measured in a sit to stand test, 30m. pace walk and a 9 step stair climb test. Additionally isometric strength in knee flexion- and extension will be measured.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Status
unknown

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

October 18, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

October 18, 2018

Last Update Submit

October 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in self reported knee function

    Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)

    At baseline and 10 weeks follow up

Secondary Outcomes (4)

  • Change in functional capacity

    At baseline and 10 weeks follow up

  • Change in isometric strength

    At baseline and 10 weeks follow up

  • Change in functional capacity

    At baseline and 10 weeks follow up

  • Change in functional capacity

    At baseline and 10 weeks follow up

Study Arms (2)

Variable load training

EXPERIMENTAL

The participants will be training two times per week in 10 weeks. Training will consist of variable load training in knee flexion- and extension. Training will be based on symptoms in isometric strength at five different angles of flexion- and extension.

Other: Variable load training

Conventional strength training

ACTIVE COMPARATOR

The participants will be training two times per week in 10 weeks. Training will consist of a training programme consisting of strength training with rubber bands for hip and knee.

Other: Conventional strength training

Interventions

Based on symptoms/strength measured in an isometric maximum strength test at five different angles of knee flexion- and extension, participants will be training with variable load during both concentric and excentric phase of the dynamic movement. Initially participants will start at 40% of symptom limited isometric strength, this will increase to 50% during the training period.

Variable load training

Conventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction.

Conventional strength training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee pain and minimum three of the following
  • \>50 years
  • morning stiffness \< 30 min
  • crepitation
  • bone tenderness
  • bone osteophytes
  • absence of inflammation

You may not qualify if:

  • Other causes of symptoms to the knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 26, 2018

Study Start

October 22, 2018

Primary Completion

December 31, 2019

Study Completion

September 1, 2020

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share