Effect of Structured Info and Adapted Exercise in OA

Osteoarthritis Clinical Trial

Official title:

The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis - an Observational Study With Control Group.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022566
• Other study ID #: 747-08
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: June 2018

Study information

• Verified date: December 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee.

The hypothesis of this study is that a supported self management of osteoarthritis program will increase the level of physical activity in patients with osteoarthritis in hip or knee. The second hypothesis is that patients with osteoarthritis in knee will increase their level of physical activity more than patients with osteoarthritis in hip.

Description:

Osteoarthritis (OA) is one of our most common chronic joint disorders. The World Health Organization (WHO) has estimated that every second woman and every fourth man over the age of 60 suffer some form of OA. OA is most common in hands, knee, hip and back. OA is a rheumatic disorder which affects the whole joint and may start as early as in the age of 30. The main symptoms are pain, stiffness and decreased quality of life.

The primary goals of OA management are to reduce the symptoms. Patient education and exercises are recommended as basic treatment according to national as well as international guidelines.

It is known that the level of physical activity decreases with age and that woman are less physical active than men. A study of healthy women older than 56 years showed that the level of activity decreased by 10 minutes per year, for every five year increase in age. OA is more common in women and is an irreversible disease, which means that the proportion of older women with osteoarthritis is large.

In addition OA is the most common cause of inactivity among the elderly and many fear that activity will further damage the joints. Inactivity is a large risk factor for poor physical and psychological health as well as premature death. Level of physical activity in people with OA has mainly been evaluated by self-assessment questionnaires. People with hip OA are more active than people with knee OA and the correlation between the degree of radiographic changes and physical activity is weak. Only 30% with early OA of the knee in the age group 35-65 years meet the recommendations for physical activity performed at least 30 minutes per day of moderate intensity, five days per week, measured by an accelerometer.

The primary aim of this study is to determine the effects of structured information and individually adapted exercises, delivered as a supported self-management osteoarthritis program, on overall levels of physical activity of moderate and vigorous intensity in patients with hip or knee OA. The secondary aim is to compare the level of physical activity in patients with hip and knee OA.

Supported self-management program for patients with osteoarthritis has been studied before and it's shown that it improves the quality of life, the physical function and decrease pain. No studies have investigated the effect of supported self-management on the level of physical activity.

This is an observational study with control group. Assessments are made at baseline and at 3 and 12 month after the supported self-management course.

The self-management program comprise three theoretical sessions, each of about 90 minutes, led by a physical therapist and held as group sessions with about 10 participants in each group. On the third session an osteoarthritis communicator participates. That is a person with osteoarthritis who communicate the lifestyle changes he/she have done to live a good life with OA. After the theoretical part the patients are offered an individually adapted exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist twice per week for 6 weeks. Patients are also encouraged to find one or two exercises to perform continuously as home exercises. During the program home exercise and other alternatives as changing activity, using walking sticks, pain management ect are introduced in order to maintain the level of physical activity over an extended period of time. The importance of being physically active for a long time is accentuated in all aspects of the patient education. The primary aim of the supported self-management program is to increase the level of physical activity and empower patients to manage their disease, avoid illness and live a good life despite osteoarthritis.

Physical activity is measured with an accelerometer at baseline, 3 month and 12 month. We will also study the correlation between objectivity measured physical activity with physical activity questionnaire (UCLA), quality of life (EQ-5D), pain (VAS 0-100) and comorbidity.

All subjects in our study are also registered in a Swedish national quality register called Better management of patients with osteoarthritis (BOA). Some of the data used in the present study are collected from the register.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75 years old.

2. Patients with clinically verified OA, coming to see a physical therapist for the Supported self-management of osteoarthritis program.

Exclusion Criteria:

1. Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).

2. Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).

3. Total joint replacement surgery within the past 12 months.

4. Other surgery of knee or hip within the past 3 months.

5. Unable to read and understand Swedish and follow verbal and visual instructions.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• A supported self management of osteoarthritis program
Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.

Locations

Country	Name	City	State
Sweden	Skånes universitets sjukhus	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	The Swedish Rheumatism Ass, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Physical Activity/Sedentary Time	The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.	Baseline, 3 months and 12 months
Primary	Level of Physical Activity/Low Activity	Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).; Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.	baseline, 3 months and12 months
Primary	Level of Physical Activity/Moderate-vigorous Activity	Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).; Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.	baseline, 3 month and 12 month
Secondary	Health Realted Quality of Life	To evaluate the health-related quality of life the EQ-5D-3L has been used. In this study, we have used the index of EQ-5D-3L with a British tariff. This scale is between (i.e., minimal value -0.594 (worst health), maximal value 1.00 (best health).	baseline, 3 months and 12 months
Secondary	Visual Analog Scale for Pain	Visual Analog Scale for Pain has been used to evaluate pain. This is a scale from 0-100 mm there higher scores indicating higher intensity of pain. We have asked for the average pain the last month.	baseline, 3 months and 12 months
Secondary	Arthritis Self-efficacy Scale/Pain (ASES)	The Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).	baseline, 3 months and 12 months