A Biomechanical Exercise Program for Knee OA
2017年1月18日 更新者：McMaster University
Clinical and Tissue Outcomes of a Biomechanical Exercise Program for Knee Osteoarthritis
Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain management, improved function, and chronic disease prevention.
Exercise that decreases joint exposure to damaging loading while eliciting adequate muscular activation for strength improvements is ideal.
The purpose of this 3-arm RCT is to compare mobility, strength, pain, and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional exercise program for knee OA (TE), and a control group completing meditation classes (M).
調査の概要
状態
完了
条件
詳細な説明
Osteoarthritis (OA) is a common joint disease affecting 1 in 10 Canadians.
Osteoarthritis commonly presents in the knee joint and is associated with mobility limitations, pain, and an increased risk of other chronic health conditions such as heart disease.
It is critical to implement exercise for people with knee OA as it can be an effective method for improving pain, mobility, and cardiovascular health.
A biomechanical exercise program using static yoga postures has been established in the investigators lab based on minimizing damaging knee joint loads, while effectively exercising the musculature around the knee joint.
The investigators pilot project (REB#13-510) showed that a 12-week yoga program using these biomechanical exercises improved pain and mobility while keeping the medial joint loading well below that experienced during normal level walking.
The next step with this exercise program is to compare clinical and tissue outcomes with that of a regularly prescribed aerobic and strengthening program, as well as a control group completing meditation classes.
The investigators aim to identify differences in clinical mobility performance outcomes, muscle and fat volumes using magnetic resonance imaging (MRI), and cartilage integrity using MRI between the three groups using a randomized controlled trial (RCT) design.
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8P 3Y4
- McMaster University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- 50 years of age or older
- Knee pain on most days of the week
- Less than 30 minutes of morning stiffness
- Bony enlargement
- Bony tenderness to palpation
- Signs of inflammation
- Able to safely climb 2 flights of stairs without aid
Exclusion Criteria:
- Any other forms of arthritis
- Osteoporosis
- History of patellofemoral symptoms
- Active non-arthritic knee disease
- Knee surgery
- Use of cane or walking aid
- Unstable heart condition
- Neurological conditions
- Skin allergy to medical tape
- Hip or ankle injuries in past 3 months
- Any injuries that would prohibit participation in yoga
- Ipsilateral hip or ankle conditions
- Currently receiving cancer treatment
- Currently pregnant
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Biomechanical Exercise (BE)
The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor.
Four class times will be offered per week.
These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises.
Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention).
Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.
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A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks.
Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
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アクティブコンパレータ：Traditional Exercise (TE)
The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA.
The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching.
Participants will be asked to come to class 3 times per week for 12 weeks.
Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.
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A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks.
Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
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他の：Meditation Control (M)
The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation.
This will take place at an alternate yoga studio to avoid contamination.
Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.
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A meditation program acting as a control will be administered 3 times a week for 12 weeks.
Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Lower Extremity Function
時間枠：Week 1 and Week 13
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The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running.
The LEFS is scored from 0 to 80 with higher scores represent better self-reported physical function.
It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.
The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
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Week 1 and Week 13
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Self-reported Knee Pain
時間枠：Week 1 and Week 13
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Change in self-reported knee pain was assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and the Numeric Pain Rating Scale (NPRS).
The KOOS pain score represents a normalized score from 0 (extreme symptoms) to 100 (no symptoms).
KOOS scores closer to 100 indicate fewer symptoms.
The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items).
The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain).
ICOAP scores closer to 0 indicate less pain.
The NPRS pain score represents a score from 0 (no pain) to 10 (worst possible pain).
NPRS ratings were provided following maximum isometric knee extensor exertions and flexor exertions.
The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Arthritis-related Self-efficacy
時間枠：Week 1 and Week 13
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The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease.
The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions).
Higher numbers indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.
The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Depression Status
時間枠：Week 1 and Week 13
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Depression was assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect.
Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep.
The CES-D is scored from 0 to 60 with a score of 16 or higher indicating depression.
The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Frailty Status
時間枠：Week 1 and Week 13
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Frailty was assessed using the Edmonton Frail Scale (EFS).
The EFS is a brief screening interview for older adults to assess frailty that is commonly used in both inpatient and outpatient settings.
The scale covers 8 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance (defined as performance on the Timed Up and Go [TUG] test).
The test is scored out of 17, with higher scores indicating higher levels of frailty.
The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Mobility Performance (Six-Minute Walk Test)
時間枠：Week 1 and Week 13
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Mobility performance was measured using the Six-Minute Walk Test.
For this test, participants are instructed to walk as far as possible in 6 minutes.
The distance covered in 6 minutes is recorded.
This measure has produced reliable and valid data in persons with knee OA.
The mean (95% confidence interval) difference in distance in metres (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Mobility Performance (40m Walk Test)
時間枠：Week 1 and Week 13
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Mobility performance was measured using the 40m Walk Test.
This test measures the time taken to complete a fast-paced 40m walk.
This measure has produced reliable and valid data in persons with knee OA.
The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Mobility Performance (30-second Chair Stand Test)
時間枠：Week 1 and Week 13
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Mobility performance was measured using the 30-second Chair Stand Test.
This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.
This measure has produced reliable and valid data in persons with knee OA.
The mean (95% confidence interval) difference in number (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Mobility Performance (Timed Up and Go Test)
時間枠：Week 1 and Week 13
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Mobility performance was measured using the Timed Up and Go Test.
This test measures the time taken to rise from a standard chair with arm rests, walk 3m, and return to a seated position.
This measure has produced reliable and valid data in persons with knee OA.
The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Mobility Performance (Stair Ascent)
時間枠：Week 1 and Week 13
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Mobility performance was measured using the Stair Ascent Test.
For this test, the time taken to ascent nine stairs is recorded.
The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Isometric Knee Extensor and Flexor Strength
時間枠：Week 1 and Week 13
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The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer.
The mean (95% confidence interval) difference in torque (follow-up - baseline) was computed for each of the three study arms.
Data is presented as Nm/kg.
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Week 1 and Week 13
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Change in Isokinetic Knee Extensor and Flexor Power
時間枠：Week 1 and Week 13
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The peak isokinetic torque developed during knee extension and flexion at 25% resistance of their maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer.
The mean (95% confidence interval) difference in power (follow-up - baseline) was computed for each of the three study arms.
Data is expressed in W/kg.
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Week 1 and Week 13
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Change in Grip Strength (Absolute)
時間枠：Week 1 and Week 13
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Peak grip strength was assessed using a Jamar hand dynamometer.
The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg.
The mean (95% confidence interval) difference in absolute force (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Grip Strength (Relative)
時間枠：Week 1 and Week 13
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Peak grip strength was assessed using a Jamar hand dynamometer.
The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg/kg (grip force/body mass).
The mean (95% confidence interval) difference in relative force (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Cardiovascular Fitness
時間枠：Intended to be collected on week 1 and week 13
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Cardiovascular fitness will be calculated using the YMCA submaximal cycle ergometry test.
Predictions of VO2max will be made from heart rate (measured with a heart rate monitor) and load (Watts).
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Intended to be collected on week 1 and week 13
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Change in Muscle and Fat Volume
時間枠：Indented to be collected on week 1 and week 13
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Muscle and fat volumes from magnetic resonance images will be segmented using a custom program.
The images will be acquired using a • Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation (IDEAL) sequence on a 3.0T MR750 Discovery research-grade scanner.
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Indented to be collected on week 1 and week 13
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Change in Cartilage Morphology
時間枠：Week 1 and Week 13
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Cartilage morphology will be assessed in open-sourced and custom programs.
Sodium (23Na+) images and T2 mapping will be completed on the 3.0T MR750 DIscovery research-grade scanner.
The mean (95% confidence interval) percent change from baseline to follow-up was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Inflammatory Markers (IL6, TNF, IL10)
時間枠：Week 1 and Week 13
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Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), and interleukin-10 (IL10) are important markers of the inflammatory response.
These markers will be assessed using standard blood draw and nasal swabs collected by a medical professional.
The mean (95% confidence interval) difference in concentration in pg/ml (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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Change in Inflammatory Markers (CRP)
時間枠：Week 1 and Week 13
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C-reactive protein (CRP) is an important marker of the inflammatory response.
This markers will be assessed using standard blood draw and nasal swabs collected by a medical professional.
The mean (95% confidence interval) difference in concentration in ug/ml (follow-up - baseline) was computed for each of the three study arms.
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Week 1 and Week 13
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Monica R Maly, PT, PhD、McMaster University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年8月1日
一次修了 (実際)
2016年7月1日
研究の完了 (実際)
2016年7月1日
試験登録日
最初に提出
2015年2月9日
QC基準を満たした最初の提出物
2015年2月18日
最初の投稿 (見積もり)
2015年2月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月10日
QC基準を満たした最後の更新が送信されました
2017年1月18日
最終確認日
2017年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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