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Effect of Structured Info and Adapted Exercise in OA

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02022566
Enrollment
317
Registered
2013-12-30
Start date
2009-04-30
Completion date
2018-06-30
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis knee, Osteoarthritis hip, Physical activity, accelerometer

Brief 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.

Detailed 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.

Interventions

BEHAVIORALA 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.

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
The Swedish Rheumatism Ass
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of Physical Activity/Sedentary TimeBaseline, 3 months and 12 monthsThe 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.
Level of Physical Activity/Low Activitybaseline, 3 months and12 monthsLevel 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.
Level of Physical Activity/Moderate-vigorous Activitybaseline, 3 month and 12 monthLevel 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.

Secondary

MeasureTime frameDescription
Health Realted Quality of Lifebaseline, 3 months and 12 monthsTo 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).
Visual Analog Scale for Painbaseline, 3 months and 12 monthsVisual 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.
Arthritis Self-efficacy Scale/Pain (ASES)baseline, 3 months and 12 monthsThe 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).

Countries

Sweden

Participant flow

Recruitment details

Because of a large drop out from the Accelerometer assessment, we recruit more participants

Participants by arm

ArmCount
Supported Self-management of Osteoarthrits Program
Treatment with an supported self-management program for osteoarthritis. 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.
195
Control Group
No intervention
69
Total264

Baseline characteristics

CharacteristicSupported Self-management of Osteoarthrits ProgramControl GroupTotal
Age, Continuous60 years
STANDARD_DEVIATION 10
66 years
STANDARD_DEVIATION 7
64 years
STANDARD_DEVIATION 9
Arthritis Self-Efficacy Scale-other symptoms, Likert scale 10-100, (10 worst, 100 best)68 units on a scale (10-100)61 units on a scale (10-100)66 units on a scale (10-100)
Arthritis Self-Efficacy Scale-pain, Likert scale 10-100, 10 worst, 100 best60 units on a scale (10-100)46 units on a scale (10-100)58 units on a scale (10-100)
BMI28 kg/m2
STANDARD_DEVIATION 5
28 kg/m2
STANDARD_DEVIATION 5
28 kg/m2
STANDARD_DEVIATION 5
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
A
55 Participants24 Participants79 Participants
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
B
81 Participants23 Participants104 Participants
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
C
59 Participants22 Participants81 Participants
Education
elementary school
47 Participants24 Participants71 Participants
Education
high school
78 Participants25 Participants103 Participants
Education
university
70 Participants20 Participants90 Participants
EuroQol 5 Dimension index, minimal value -0.594 (worst health), maximal value 1.00 (best health)0.725 EQ-5D index0.656 EQ-5D index0.692 EQ-5D index
Joint
hip
43 Participants31 Participants74 Participants
Joint
knee
152 Participants38 Participants190 Participants
Low activity daily minutes180 minutes169 minutes178 minutes
Moderate-vigorous activity daily minutes34 minutes20 minutes30 minutes
Sedentary daily minutes562 minutes572 minutes565 minutes
Sex/Gender, Customized
female
125 Participants40 Participants165 Participants
Sex/Gender, Customized
men
70 Participants29 Participants99 Participants
Visual Analogue Scale pain (0 to 100, 0=no pain, 100=worst imaginable pain51 units on a scale60 units on a scale54 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1950 / 69
other
Total, other adverse events
0 / 1950 / 69
serious
Total, serious adverse events
0 / 1950 / 69

Outcome results

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.

Time frame: baseline, 3 months and12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Low Activitybaseline181 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Low Activity3 months170 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Low Activity12 months178 minutes
Control GroupLevel of Physical Activity/Low Activitybaseline169 minutes
Control GroupLevel of Physical Activity/Low Activity3 months169 minutes
Control GroupLevel of Physical Activity/Low Activity12 monthsNA minutes
p-value: <0.05ANOVA
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.

Time frame: baseline, 3 month and 12 month

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Moderate-vigorous Activitybaseline34 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Moderate-vigorous Activity3 month34 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Moderate-vigorous Activity12 month32 minutes
Control GroupLevel of Physical Activity/Moderate-vigorous Activitybaseline20 minutes
Control GroupLevel of Physical Activity/Moderate-vigorous Activity3 month21 minutes
Control GroupLevel of Physical Activity/Moderate-vigorous Activity12 monthNA minutes
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.

Time frame: Baseline, 3 months and 12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Sedentary Timebaseline562 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Sedentary Time3 months556 minutes
Supported Self-management of Osteoarthrits ProgramLevel of Physical Activity/Sedentary Time12 months552 minutes
Control GroupLevel of Physical Activity/Sedentary Timebaseline572 minutes
Control GroupLevel of Physical Activity/Sedentary Time3 months556 minutes
Control GroupLevel of Physical Activity/Sedentary Time12 monthsNA minutes
p-value: <0.05ANOVA
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).

Time frame: baseline, 3 months and 12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Pain (ASES)baseline60 units on a scale
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Pain (ASES)3 months74 units on a scale
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Pain (ASES)12 months68 units on a scale
Control GroupArthritis Self-efficacy Scale/Pain (ASES)baseline46 units on a scale
Control GroupArthritis Self-efficacy Scale/Pain (ASES)3 months50 units on a scale
Control GroupArthritis Self-efficacy Scale/Pain (ASES)12 monthsNA units on a scale
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).

Time frame: baseline, 3 months and 12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramHealth Realted Quality of Lifebaseline0.73 eq-5d index
Supported Self-management of Osteoarthrits ProgramHealth Realted Quality of Life3 months0.73 eq-5d index
Supported Self-management of Osteoarthrits ProgramHealth Realted Quality of Life12 months0.73 eq-5d index
Control GroupHealth Realted Quality of Lifebaseline0.66 eq-5d index
Control GroupHealth Realted Quality of Life3 months0.52 eq-5d index
Control GroupHealth Realted Quality of Life12 monthsNA eq-5d index
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.

Time frame: baseline, 3 months and 12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramVisual Analog Scale for Painbaseline51 units on a scale
Supported Self-management of Osteoarthrits ProgramVisual Analog Scale for Pain3 months37 units on a scale
Supported Self-management of Osteoarthrits ProgramVisual Analog Scale for Pain12 months38 units on a scale
Control GroupVisual Analog Scale for Painbaseline60 units on a scale
Control GroupVisual Analog Scale for Pain3 months62 units on a scale
Control GroupVisual Analog Scale for Pain12 monthsNA units on a scale
Post Hoc

Arthritis Self-efficacy Scale/Other Symptoms

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).

Time frame: baseline, 3 months and 12 months

ArmMeasureGroupValue (MEDIAN)
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Other Symptomsbaseline68 units on a scale
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Other Symptoms3 months76 units on a scale
Supported Self-management of Osteoarthrits ProgramArthritis Self-efficacy Scale/Other Symptoms12 months71 units on a scale
Control GroupArthritis Self-efficacy Scale/Other Symptomsbaseline61 units on a scale
Control GroupArthritis Self-efficacy Scale/Other Symptoms3 months56 units on a scale
Control GroupArthritis Self-efficacy Scale/Other Symptoms12 monthsNA units on a scale

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026