## Protocol Section
### Identification Module
**NCT ID:** NCT01797679

**Brief Title:** Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

**Official Title:** Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** NFR213335/h10
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Akershus
### Status Module
#### Completion Date
**Date:** 2017-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-01-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-10

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2014-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-03

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2013-02-22
**Type:** ESTIMATED
**Study First Submit Date:** 2013-02-21
**Study First Submit QC Date:** 2013-02-21
**Why Stopped:** Lack of agreement between the participants and lack og funding
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Research Council of Norway

**Class:** OTHER

**Name:** Oslo University Hospital

**Class:** OTHER

**Name:** Hjelp24

**Class:** OTHER

**Name:** South-Eastern Norway Regional Health Authority

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Akershus

#### Responsible Party

**Investigator Affiliation:** University Hospital, Akershus

**Investigator Full Name:** Hasan Banitalebi

**Investigator Title:** Radiologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.

### Conditions Module

**Conditions:**

- Osteoarthritis

**Keywords:**

- Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.

Intervention: Other: Strength training

**Intervention Names:**

- Other: Strength Training

**Label:** Strength Training

**Type:** OTHER

#### Arm Group 2

**Description:** The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 85% of maximal heart rate.

**Intervention Names:**

- Other: Aerobic Exercise

**Label:** Aerobic exercise

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** The control group will do as usual.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Strength Training

**Name:** Strength Training

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Aerobic exercise

**Name:** Aerobic Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Indirect cartilage morphology will by assessed by X-ray Direct cartilage morphology will be assessed by MRI morphometry The biochemical composition of the cartilage will be assessed by relaxometry (T2 and T1 rho relaxation times)

**Measure:** Qualitative Cartilage Morphology Assessment

**Time Frame:** One year

#### Secondary Outcomes

**Description:** Using semiquantitative techniques, the clinical manifestations of osteoarthritis assessed by MRI such as: cartilage lesions and bone marrow lesions will be assessed and quantified by MRI.

**Measure:** Semiquantitative Cartilage Assessment

**Time Frame:** One year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women and men aged 45-65 years
* Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
* Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

* Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
* Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
* Known coronary heart diseases or cancer
* Body mass index \> 35
* Scheduled for surgery in any joint
* Known mental or psychologic diseases
* Known drug abuse
* Persons who already perform sports related moderate physical activity more than two times a week
* Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital)
* Not speaking Norwegian

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lorenskog

**Country:** Norway

**Facility:** Akershus University Hospital

**Zip:** 1478

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

### Misc Info Module

- Version Holder: 2024-05-24
