Chronic DiseasesNCT00126737
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
A study testing Home-based exercise program in people with Chronic Diseases and Obesity, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Diseases, Obesity, Osteoarthritis
- What is being tested?
- Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male \& female 50 years old
- Diagnosis of osteoarthritis by American College of Rheumatology criteria
- Knee radiographs of Kellgren and Lawrence grade 2-4
- American Arthritis Association functional class 1-3
- Body mass index of 27
Who cannot join
- Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
- Unable to engage in exercise or follow instruction
- Limited shoulder range of motion
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-3030
About this study
The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.
Read the detailed description
Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.
- Conditions
- Chronic Diseases, Obesity, Osteoarthritis, Pain
- Being tested
- Weight Control Nutritional Program, Home-based exercise program
- Keywords
- Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, stair climb, walking distance, weight loss
- Medical subject headings
- Chronic Disease, Obesity, Osteoarthritis, Pain, Motor Activity, Agnosia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Control Nutritional ProgramOther
Also called pole striding walking exercise
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
Home-based exercise programOther
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Receives: Other: Weight Control Nutritional Program; Other: Home-based exercise program |
| Arm 2 | Active comparator | Group assigned to a Weight Control Nutritional Program (WC). Receives: Other: Weight Control Nutritional Program |
| Arm 3 | Active comparator | Group assigned to a home-based exercise program (Ex). Receives: Other: Home-based exercise program |
| Arm 4 | No intervention | Usual care and non- specific health information (C). |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Function
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.
Measured: Between Base-line and 24 weeks
Physical Scale SF-36v
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.
Measured: Between Base-line and 24 weeks
Mental Scale SF-36v
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.
Measured: Between Base-line and 24 weeks
Secondary outcomes (2)
Walking Distance
Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
Measured: Between Base-line and 24 weeks
Stair Total (Climb, Descend)
Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.
Measured: Between Base-line and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startOct 2002
- Primary completionFeb 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elly Budiman-Mak, MS MPH MD, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126737
- Sponsor's protocol ID
- E2920-R
- Status last verified
- Dec 2014
- First submitted
- 2 Aug 2005
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Collins E, O'Connell S, Jelinek C, Miskevics S, Budiman-Mak E. Evaluation of psychometric properties of Walking Impairment Questionnaire in overweight patients with osteoarthritis of knee. J Rehabil Res Dev. 2008;45(4):559-66. doi: 10.1682/jrrd.2007.04.0053.
PubMed 18712641Wolf S, Foley S, Budiman-Mak E, Moritz T, O'Connell S, Jelinek C, Collins EG. Predictors of weight loss in overweight veterans with knee osteoarthritis who participated in a clinical trial. J Rehabil Res Dev. 2010;47(3):171-81. doi: 10.1682/jrrd.2009.08.0136.
PubMed 20665344Possley D, Budiman-Mak E, O'Connell S, Jelinek C, Collins EG. Relationship between depression and functional measures in overweight and obese persons with osteoarthritis of the knee. J Rehabil Res Dev. 2009;46(9):1091-8. doi: 10.1682/jrrd.2009.03.0024.
PubMed 20437315
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00126737
- Acronym / sponsor ID
- E2920-R
- Conditions
- Chronic Diseases, Obesity, Osteoarthritis, Pain
- Keywords
- Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, stair climb, walking distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Aug 2005 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.
Detailed description
Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: Weight Control Nutritional Program, Other: Home-based exercise programGroup assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). |
| Arm 2 | Active comparator | Other: Weight Control Nutritional ProgramGroup assigned to a Weight Control Nutritional Program (WC). |
| Arm 3 | Active comparator | Other: Home-based exercise programGroup assigned to a home-based exercise program (Ex). |
| Arm 4 | No intervention | –Usual care and non- specific health information (C). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male \& female 50 years old
- Diagnosis of osteoarthritis by American College of Rheumatology criteria
- Knee radiographs of Kellgren and Lawrence grade 2-4
- American Arthritis Association functional class 1-3
- Body mass index of 27
Key exclusion criteria (3 listed)
- Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
- Unable to engage in exercise or follow instruction
- Limited shoulder range of motion
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 |
|---|---|---|
| Weight Control Nutritional ProgramAlso: pole striding walking exercisea week of food diary and information about dietary fat intake and proper proportions of vegetables. | Other | Arm 1, Arm 2 |
| Home-based exercise program24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises. | Other | Arm 1, Arm 3 |
Primary outcome
WOMAC Function
Time frame: Between Base-line and 24 weeks
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.
Physical Scale SF-36v
Time frame: Between Base-line and 24 weeks
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.
Mental Scale SF-36v
Time frame: Between Base-line and 24 weeks
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.
2 secondary outcomes
Walking Distance
Time frame: Between Base-line and 24 weeks
Stair Total (Climb, Descend)
Time frame: Between Base-line and 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18712641Collins E, O'Connell S, Jelinek C, Miskevics S, Budiman-Mak E. Evaluation of psychometric properties of Walking Impairment Questionnaire in overweight patients with osteoarthritis of knee. J Rehabil Res Dev. 2008;45(4):559-66. doi: 10.1682/jrrd.2007.04.0053.
- Results publication: PubMed 20665344Wolf S, Foley S, Budiman-Mak E, Moritz T, O'Connell S, Jelinek C, Collins EG. Predictors of weight loss in overweight veterans with knee osteoarthritis who participated in a clinical trial. J Rehabil Res Dev. 2010;47(3):171-81. doi: 10.1682/jrrd.2009.08.0136.
- Results publication: PubMed 20437315Possley D, Budiman-Mak E, O'Connell S, Jelinek C, Collins EG. Relationship between depression and functional measures in overweight and obese persons with osteoarthritis of the knee. J Rehabil Res Dev. 2009;46(9):1091-8. doi: 10.1682/jrrd.2009.03.0024.
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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.
Elly Budiman-Mak, MS MPH MD principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program in people with Chronic Diseases and Obesity, run by US Department of Veterans Affairs at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
WOMAC Function (time frame: Between Base-line and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126737, which also lists 3 linked publications.
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 1 Jan 2015.