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The Effects of a 6-week Balance, Agility, Strengthening Exercise Class

2020年3月19日 更新者:Karen Dobbin、University of Manitoba

The Effects of a 6-week Balance, Agility, Strengthening Exercise (BASE) Class on Balance Performance, Self-Efficacy, and Fear of Falling in Cancer Survivors

Cancer treatments can have a significant impact on a cancer survivor's function and independence, and these patients can have twice the incidence of falls than their cancer-free peers. Balance programs of varying lengths have shown to improve balance performance, increase self-efficacy and decrease fear of falling; however, there are limited intervention studies amongst cancer survivors, and none that examine the combination of balance performance, self-efficacy and fear of falling. It is believed that this study will show that a 6-week Balance, Agility, Strengthening Exercise (BASE) Class is a sufficient time frame to demonstrate a positive effect on balance performance, self-efficacy, and fear of failing in cancer survivors, and will add to the body of knowledge in this population.

調査の概要

詳細な説明

Objectives Given that this combination of outcomes have not been sufficiently measured in the cancer population, and most balance and agility training programs are 12 weeks or more in length, the objectives of this study is to determine the effects of a 6-week intervention, the Balance, Agility, Strengthening Exercise (BASE) Class, on the balance performance, self-efficacy, and the fear of falling in cancer survivors.

Methods This study is a 3 year exercise interventional study, with 20 participants per year. In year one of the study, 20 participants will be enrolled in a 6-week Balance, Agility, Strengthening Exercise (BASE) Class. The pre-program data collection will include: demographic data; initial intake examination utilizing standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life. The participants will attend the BASE class twice weekly for 6-weeks. The post-program data collection is to include the same outcome measures.

Subsequent years will be an observational study of the same design, enrolling 20 participants in year 2 and 3 for a 6-week BASE class. A total of 60 participants will be recruited over 3 years providing adequate power to assess program efficacy. Based on the resources available, this study can only accommodate 20 participants per year and can only be conducted for a 6-week period each year of the study.

Participants and recruitment Posters and hand bills will be distributed and placed throughout CancerCare recruiting participants for the study (self-referral). In addition, hand bills will provided for oncologists, oncology nurses, and psychosocial clinicians to give to patients/potential participants within the clinical areas at CancerCare. After receiving the hand bill with the study description and information, potential participants can choose to phone or e-mail the PI to indicate their interest in the study. A phone interaction will take place between the PI and potential participant to determine if they meet the inclusion criteria. Once it is determined that they meet the inclusion criteria, an in-person meeting will be arranged and they will be provided with the study's objectives, risks and benefits, and the consent document. Time will be allowed for the potential participant to ask questions and to consider their enrollment in the study. After a thorough discussion and review of the documents, the potential participant will be asked to sign the consent form. If requested, a person will be allowed to take the consent form home for further consideration prior to signing.

Data collection Prior to the start of the BASE Class, an initial assessment will take place. This assessment will utilize standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life.

Intervention:

The BASE class will run twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

Statistical Analysis Pre-post paired comparisons will be conducted for each balance performance and self-reported questionnaire measure. A paired T-test or Wilcoxon signed ranks test will be performed according to the observed distributions.

研究の種類

介入

入学 (予想される)

60

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。

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

18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

全て

説明

Inclusion Criteria:

  • community-dwelling
  • ambulatory
  • diagnosed with hematological or solid cancer tumors (except brain tumors/brain metastases)
  • age >18 years
  • self-identified as experiencing impaired balance, and scoring less than 80% on the Activities-specific Balance Confidence Scale
  • able to communicate in English

Exclusion Criteria:

  • metastatic cancer
  • those unable to provide informed consent
  • those having previously received physiotherapy and exercise instruction from the principal investigator.

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:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Interventional
Balance, Agility, Strengthening Exercise (BASE) class intervention - a 6-week exercise class to determine the change in balance performance, fear of falling and self-efficacy
The BASE class will be conducted twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

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
Balance Performance - miniBest
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Mini-Balance Evaluation Systems Test is a 14-item balance scale covering a broad spectrum of performance tasks including dynamic body stability, transfers, gait, variation of support surfaces, and of visual conditions, obstacle negotiation, reactions to external forces and performance during dual-tasking.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performane - TUG
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Timed Up and Go: a rise from a chair, 3-meter walk, turn and walk back to chair and sitting. Designed to measure mobility, balance, and locomotor performance; evaluates falls risk and basic functional mobility.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Timed Unipedal Stance Test
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A simple test for measuring static aspects of balance ability, measured in seconds with eyes open and eyes closed; useful when combined with other balance performance tests.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - 6-meter Gait Speed Test
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A 6-meter walking test measured in meters/second; an indicator of walking ability, function, and mobility.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Four Square Step Test
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A timed measurement of stepping whilst changing direction to provide a measure of dynamic standing balance and mobility; stepping forwards, sideways, and backwards over obstacles in a specified sequence.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

二次結果の測定

結果測定
メジャーの説明
時間枠
Self-report ABC Scale
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Activities-specific Balance Confidence Scale is a 16-item self-report questionnaire examining a person's confidence in a broad range of activities with various difficulties; to assess balance confidence in ambulatory community-dwelling older adults
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report MFES
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Modified Fall Efficacy Scale International is a 15 question self-rated scale assessing a person's confidence in performing activities in the home, plus additional items related to outdoor activities.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
self-report Fear of Falling
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A 14 item scale that examines fear of falling and the effect it has on participation in various activities
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report Quality of Life FACT-G
時間枠:1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Functional Assessment of Cancer Therapy - General is a 27-item self-report instrument that consists of 4 sub-scales: physical well-being, social well-being, emotional well-being, and functional well-being to measure quality of life for cancer patients.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

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

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 (予想される)

2020年4月6日

一次修了 (予想される)

2022年6月30日

研究の完了 (予想される)

2023年1月1日

試験登録日

最初に提出

2020年3月17日

QC基準を満たした最初の提出物

2020年3月19日

最初の投稿 (実際)

2020年3月24日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月24日

QC基準を満たした最後の更新が送信されました

2020年3月19日

最終確認日

2020年3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

  • H2019:470

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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