Intervention for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta, Edmonton, Canada
Obesity+2 More
Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can improve physical function in people with knee osteoarthritis.

See full description

Eligible Conditions

  • Obesity
  • Osteoarthritis, Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Intervention will improve 5 primary outcomes, 3 secondary outcomes, and 13 other outcomes in patients with Obesity. Measurement will happen over the course of at interim (3 months).

at interim (3 months)
Adverse events
Per-protocol adherence (feasibility)
Month 10
Acceptability of Intervention Measure (AIM) score
Qualitative data on participants perceptions of acceptability
Month 10
Study completion rates (feasibility)
Month 10
albumin
c-reactive protein
fat mass
glucose
insulin
lipid panel
liver enzymes
muscle mass
muscle quality
patient-reported arthritis-related pain and function
patient-reported health-related quality of life
physical function (6MWT distance)
physical function (chair stands)
resting energy expenditure
self-efficacy for managing chronic disease
thyroid stimulating hormone

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention
Behavioral
The intervention group will receive initial nutrition and exercise consultations with a Registered Dietitian (RD) and Clinical Exercise Physiologist (CEP) to personalize the study protocol and recommendations to their needs. The intervention period (3 months) includes: a) whole-body resistance training exercise sessions completed three-times per week (at-home with loaned equipment and/or in-person at the research gym); b) biweekly nutrition education provided through video conferencing; and c) biweekly OA self-management support provided through video conferencing. After the 3 month intervention, participants will receive bimonthly phone calls from a study staff member to encourage continued behavior changes during the 6 month maintenance phase.
Usual CareThe control group will follow standard care procedures, which includes their usual activities. The control group will receive bimonthly contact during the study period through phone calls with a study staff member to encourage retention. However no recommendations or advice on nutrition, exercise or self-management will be provided.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73850

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at interim (3 months) and study completion (10 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at interim (3 months) and study completion (10 months) for reporting.

Closest Location

University of Alberta - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Osteoarthritis that affects only one or both knees and is classified as a grade 2 or higher on the KL scale, along with accompanying symptoms. show original
They will need to have a reliable and unlimited internet connection, and a laptop, computer, or tablet to join videoconferencing sessions from home. show original
The person has a BMI of ≥35 kg/m2. show original
Can write and understand English well enough to provide written consent. show original
able to attend assessment appointments in Edmonton, Alberta
Can do exercises at home with equipment provided, or attend in-person exercise sessions. show original

Patient Q&A Section

How many people get arthrosis a year in the United States?

"Arthrosis is so common that it is necessary to have a system to quantify how many people have it. The data to compute an estimated number of people affected by arthrosis are based on the most-recent data available from national surveys performed by the U.S. Centers for Disease Control and Prevention, as of 1999." - Anonymous Online Contributor

Unverified Answer

What causes arthrosis?

"Arthrosis can be caused by systemic, metabolic or genetic disease. Other causative factors include trauma, physical overuse, or excessive mechanical movement such as in rheumatoid arthritis or osteoarthritis or in aseptic loosening in a prosthetic or bone implant, in which case it can be classified as osteolysis. The diagnosis of arthrosis is a clinical judgment, but a combination of clinical signs and joint fluid examination can be helpful. Treatment of arthrosis may include rest or physical therapy exercises to relieve joint swelling and pain. If no improvement occurs, referral to an orthopedist may be warranted." - Anonymous Online Contributor

Unverified Answer

Can arthrosis be cured?

"In view of the success achieved in the treatment of other joint anomalies, such as [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis) and spondyloarthropathy, it appears appropriate to consider the possibility of a cure for arthrosis and other types of localised arthritis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthrosis?

"Arthrosis is a disease of the joints that occurs in about 9% of adults. It involves a range of pathological lesions occurring in the joint, and it is a major source of pain, as the joints become inflamed and damaged. Arthrosis often begins at an early age and may be an early stage in the process of developing osteoarthritis in later life. Over the past decade, great advances have been made in defining the various pathogenic pathways that lead to the development of both acute and chronic osteoarthritis, and there is a growing consensus on which treatments could be best used to prevent and to treat the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthrosis?

"Arthrosis has few signs in comparison to degenerative arthritis such as stiffness, increased pain, decreased range of motion and muscle atrophy. The presence of a history of pain is a sign of arthrosis." - Anonymous Online Contributor

Unverified Answer

What is arthrosis?

"A arthritis is a group of inflammatory and autoimmune diseases of joints, which result in a gradual degradation of joint structures and the consequent development of joint pain and stiffness. Most frequently, the affected joints are those of the hands and feet. Arthritis is more common in women than in men and can be encountered in both the juvenile and the adult population. It has multiple manifestations including joint pain, stiffness, and aching. Osteoarthritis of the knee is the most common kind of arthritis in women. Arthritis is an inflammatory disease, and it is thought to be connected to the immune system and autoimmune diseases including rheumatoid arthritis (RA) and scleroderma." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets arthrosis?

"Age at arthrosis onset varies depending on the clinical presentation. Most (≥ 90%) of patients have arthrosis onset in late life but can expect to live a normal life span. The average age of arthrosis onset is approximately 48 years of age." - Anonymous Online Contributor

Unverified Answer

What is the latest research for arthrosis?

"Because treatment and surgical intervention for arthritis remain elusive, and because arthritic patients are prone to developing additional disease, a variety of nonsurgical therapies have become a focus of clinical research. The potential for a new biological therapy may be much greater in the treatment of osteoarthritis, because the body's response to injuries is different at the site of joint destruction in osteoarthritis. For this reason, nonintraoperative therapies hold promise for the new bioprostheses and osteoinductive therapeutics." - Anonymous Online Contributor

Unverified Answer

Is intervention safe for people?

"While patients perceive their arthritis to respond to treatment with anti-TNF therapy, this does not appear to necessarily result in improvements in function and pain." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in intervention for therapeutic use?

"Recent developments in biomedical research have increased our understanding of how inflammation triggers osteoarthritis. A new generation of treatments that target inflammation, and inflammation-mediated signaling pathways, are emerging that promise to alter the current paradigm that inflammation and cartilage degradation can only result from other pathways such as mechanical trauma and joint instability. These approaches aim to improve current intervention strategies and are of major importance in treating osteoarthritis." - Anonymous Online Contributor

Unverified Answer

What is intervention?

"Results from a recent clinical trial of this study suggest that we need to consider alternative explanations for our findings and that future well-designed RCTs in OA should be implemented in the context of multidisciplinary clinical care." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of intervention?

"Results from a recent clinical trial suggests that patients with knee OA may have different side effects from those with other types of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis). Patients with medial knee OA and symptomatic gout should receive an intervention prior to total knee replacement if the risk of their knee OA is less than 40%." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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