Resistance TrainingNCT03722277
Variable Resistance Training in Patients With Osteoarthrosis of the Knee
A study testing Variable load training and Conventional strength training in people with Resistance Training, run by University College South Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resistance Training
- What is being tested?
- Variable load training and Conventional strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2018to 1 Sep 2020
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Knee pain and minimum three of the following
- >50 years
- morning stiffness < 30 min
- crepitation
- bone tenderness
- bone osteophytes
- absence of inflammation
Who cannot join
- Other causes of symptoms to the knee
About this study
Official title: Variable Resistance Training Versus Conventional Rubber Band Training: Effects on Functional Capacity and Strength in Patients With Osteoarthrosis of the Knee
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.
- Conditions
- Resistance Training
- Being tested
- Variable load training, Conventional strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable load trainingOther
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.
Conventional strength trainingOther
Conventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported knee function
Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: At baseline and 10 weeks follow up
Secondary outcomes (4)
Change in functional capacity
Sit to stand test
Measured: At baseline and 10 weeks follow up
Change in isometric strength
Isometric strength in knee flexion- and extension
Measured: At baseline and 10 weeks follow up
Change in functional capacity
30m pace walk
Measured: At baseline and 10 weeks follow up
Change in functional capacity
9 step stair climb test
Measured: At baseline and 10 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start22 Oct 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College South Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722277
- Sponsor's protocol ID
- Variable Load
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 26 Oct 2018
- 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 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Resistance Training Versus Conventional Rubber Band Training: Effects on Functional Capacity and Strength in Patients With Osteoarthrosis of the Knee
- ClinicalTrials.gov ID
- NCT03722277
- Acronym / sponsor ID
- Variable Load
- Conditions
- Resistance Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University College South DenmarkUniversity, hospital or other
- Study start
- 22 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 26 Oct 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable load training | Experimental | Other: Variable load trainingThe 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. |
| Conventional strength training | Active comparator | Other: Conventional strength trainingThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Knee pain and minimum three of the following
- >50 years
- morning stiffness < 30 min
- crepitation
- bone tenderness
Key exclusion criteria (1 listed)
- Other causes of symptoms to the knee
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 |
|---|---|---|
| Variable load trainingBased 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. | Other | Variable load training |
| Conventional strength trainingConventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction. | Other | Conventional strength training |
Primary outcome
Change in self reported knee function
Time frame: At baseline and 10 weeks follow up
Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)
4 secondary outcomes
Change in functional capacity
Time frame: At baseline and 10 weeks follow up
Change in isometric strength
Time frame: At baseline and 10 weeks follow up
Change in functional capacity
Time frame: At baseline and 10 weeks follow up
Change in functional capacity
Time frame: At baseline and 10 weeks follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Variable load training and Conventional strength training in people with Resistance Training, run by University College South Denmark.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in self reported knee function (time frame: At baseline and 10 weeks follow up). 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 26 Oct 2018.