Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
2014年2月12日 更新者：University of Florida
Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
72
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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Florida
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Gainesville、Florida、アメリカ、32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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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
60年～85年 (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
全て
説明
Inclusion Criteria:
- chronic low back pain for >6 months
- >3 pain episodes per week
- waist circumferences ≥102 cm for men
- waist circumferences ≥ 88 cm for women
- willing and able to participate in regular exercise for 14 weeks
- using pain medications to control low back pain
- free of abnormal cardiovascular responses during a screening graded maximal walk test
Exclusion Criteria:
- unable to walk
- participating in regular resistance exercise training (>3X week) in the past 6 months
- pain symptoms are too severe and prevent strength testing or walking
- acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- back surgery within the past 2 years
- current use of weight loss interventions (drugs; exercise interventions)
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：処理
- 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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アクティブコンパレータ：Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
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physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines
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アクティブコンパレータ：Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
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lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months
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アクティブコンパレータ：Total Body Resistance Exercise Program
Training protocol for 1 set for each exercise: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl
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exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months
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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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10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3 and 4 Months
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The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable.
Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
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Baseline, 1, 2, 3 and 4 Months
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Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3 and 4 Months
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Fear avoidance beliefs will be measured using the 11 item TSK.
Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
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Baseline, 1, 2, 3 and 4 Months
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Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baselinje, 1, 2, 3 and 4 Months
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The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain.
Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
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Baselinje, 1, 2, 3 and 4 Months
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Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3 and 4 Months
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The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness.
Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.
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Baseline, 1, 2, 3 and 4 Months
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Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3 and 4 Months
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The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures.
Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
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Baseline, 1, 2, 3 and 4 Months
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Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3, and 4 Months
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The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures.
Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
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Baseline, 1, 2, 3, and 4 Months
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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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Graded Treadmill Exercise Test; Change from Baseline at 4 Months
時間枠：Baseline and 4 Months
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Maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test.
Subjects will complete the exercise test at the indicated time intervals to document any change in their aerobic fitness.
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Baseline and 4 Months
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Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
時間枠：Baseline and 4 Months
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Chair rise time will be measured as the participant moves from a sitting to a full standing position.
The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 12 steps as quickly as possible.
Gait will be assessed by having the participants walk across a 26' portable walkway.
Subjects will complete these motions at the indicated time intervals to document any change.
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Baseline and 4 Months
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7-day Pedometer Test; Change from Baseline at 4 Months
時間枠：7 day period at Baseline and 4 Months
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Community ambulation will be estimated using a 7-day pedometer test in which participants will wear a StepWatch® step activity monitor.
Subjects will complete this test at the indicated time intervals to document any change in their ambulation.
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7 day period at Baseline and 4 Months
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Ultrasound Muscle Thickness; Change from Baseline at 4 Months
時間枠：Baseline and 4 Months
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The ultrasound technique that will be used to capture muscle thickness changes in the paraspinal and multifidus muscles.
Subjects will be tested at the indicated time intervals to document any change.
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Baseline and 4 Months
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Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
時間枠：Baseline, 1, 2, 3 and 4 Months
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Assessments of strength (1 repetition maximum, 1-RM) will be determined for all muscle groups trained.
Subjects will be assessed at the indicated time intervals to document any change.
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Baseline, 1, 2, 3 and 4 Months
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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
2010年11月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2010年11月5日
QC基準を満たした最初の提出物
2010年11月29日
最初の投稿 (見積もり)
2010年11月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月14日
QC基準を満たした最後の更新が送信されました
2014年2月12日
最終確認日
2014年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 258-2010
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