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The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.

2021年8月6日 更新者:Nichola Davis、University of Derby

Evaluation of the Feasibility, Psychosocial Effects, Influence and Perception of Exercise Selection and Experimental Design of Exercises Performed.

Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions.

The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults.

The study will establish the accessibility, acceptability and appropriateness of an elastic band exercise intervention with older adults by performing selected activities followed by researcher led interviews that will focus on the participants influences, perceptions and psycho-social factors related the intervention activities.

調査の概要

詳細な説明

Outline of study design The following study will be designed as a single exposure, qualitative (one-to-one interviews using a semi-structured interview guide) and quantitative (heart rate and rate of perceived exertion ratings) study. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will take part in one experimental session: performing exercises with an elastic resistance band placed at the hip and chest region. The session order of band placement will be randomized for each participant to counter-balance the outcome which emerge from the study.

Participant preparation Following a detailed briefing using a pre-prepared participant information sheet, a signed informed consent form and Instrumental Activities of Daily Living form, participants will be required to complete 2 supervised visits to the laboratory at the University of Derby.

Participants will complete a general health screening questionnaire. Specific instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation.

Outline of study methods Participants will be required to attend the University Laboratory (Kblock) to take part in the study. Due to COVID-19 participants will be required to adhere to the latest government guidance and guidance from the University to consider this assessment to be safe (Risk assessments in place).

Baseline assessments:

  • Mini Balance Evaluation (MINI BESTest)
  • Short Falls Efficacy Scale (Short FES-I)

Following a briefing, participants will be required to perform a 10 minute supervised warm up and mobility session prior to exercise. Participants will be required to perform a selection of 8 pre-selected exercises whilst wearing the elastic band around the hip or chest region (randomized) with a 20 minute rest in between each condition). Participants will perform the exercises with the lowest resistance of 2-15lb aimed at low/moderate intensity. Heart rate (HR) on a heart rate strap and watch, rate of perceived exertion (RPE) (Borg scale) will be measured to assess exercise intensity.

All sessions will be closely supervised by the lead researcher -a qualified postural stability instructor, (level 4 reps Postural Stability Instructor trained by Later Life Training), that will provide prompts on form of the exercises.

Elastic band placement

Hip region:

Each participant will be required to perform the series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level which will be attached to the participant over the hip region with padding.

Chest region Each participant will be required to perform a series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level and to the participant over the chest region (under arms) , using Velcro on a chest harness/training vest.

Immediately following the single-session exercise intervention, participants will be required to attend a one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.

研究の種類

介入

入学 (予想される)

15

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

      • Derby、イギリス、de22 11gb
        • 募集
        • University of Derby

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~80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:

  • Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
  • Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
  • Ability to walk without a walking aid
  • Ability to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired

Exclusion Criteria:

  • Individuals that are under the age of 50 years old
  • Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
  • Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are not physically active (METs score under 600 MET-min/week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE)

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:防止
  • 割り当て:ランダム化
  • 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:Hip Region

Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed around the hip region.

Warm up: 5-10 mins

Exercises:

Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold.

Cool down. Post intervention- Semi-structured Interview schedule

A single exposure feasibility study using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
他の名前:
  • 弾性レジスタンスバンドトレーニング
  • 高齢者のバランストレーニング
  • 高齢者向けのレジスタンスバンドを使用した安定性トレーニング
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • 斬新な弾性レジスタンスバンドトレーニングによる高齢者への介入
  • Feasibility study on a Novel Elastic Resistance Band training Intervention
実験的:Chest Region

Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest).

Warm up: 5-10 mins

Exercises:

Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold.

Cool down. Post intervention- Semi-structured Interview schedule

A single exposure feasibility study using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
他の名前:
  • 弾性レジスタンスバンドトレーニング
  • 高齢者のバランストレーニング
  • 高齢者向けのレジスタンスバンドを使用した安定性トレーニング
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • 斬新な弾性レジスタンスバンドトレーニングによる高齢者への介入
  • Feasibility study on a Novel Elastic Resistance Band training Intervention

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
Semi structured Interview
時間枠:through study completion, an average of 1 year
A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol. Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement. This will help to build insights into the participant preferences which is an important element of the intervention design.
through study completion, an average of 1 year
心拍数
時間枠:学習完了まで、平均1年
各エクササイズ中に心拍数の測定が行われます。 値が高いほど、実行される各エクササイズの強度が高くなります。 1 分あたり 50 拍 - 120 = 低、120 ~ 150 拍 = 中、150 拍 = 高。
学習完了まで、平均1年
Rate of perceived exertion (RPE)
時間枠:through study completion, an average of 1 year
RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion- exhaustion.
through study completion, an average of 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
ミニバランス評価試験(MINI-BESTest)
時間枠:学習完了まで、平均1年

この評価では、参加者は一連の身体パフォーマンス タスクを実行する必要があります。 各タスクの後、研究者はスコアを記録して、MINI BESTest の合計スコアを計算します。 採点: テストには 14 項目から最高 28 ポイントが与えられ、それぞれ 0 ~ 2 で採点されます。 「0」 = 最低レベルの機能、「2」 = 最高レベルの機能。

被験者が補助器具を使用しなければならない項目がある場合、その項目のスコアを 1 つ低いカテゴリにします。

被験者が項目を実行するために身体的補助を必要とする場合、その項目のスコアは「0」とします。

学習完了まで、平均1年
Short Falls efficacy scale
時間枠:through study completion, an average of 1 year
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities. The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item. A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).
through study completion, an average of 1 year

その他の成果指標

結果測定
メジャーの説明
時間枠
日常生活の手段的活動フォーム (IADL)
時間枠:学習完了まで、平均1年

参加者募集における差異を判断するために、その人が現時点でどのように機能しているかを特定するため。 IADL には 8 つのカテゴリーがあり、参加者は機能レベルに応じてスコアが割り当てられている (1 または 0) 4 つのオプションから 1 つを選択する必要があります。 スコアリングの解釈: 一部のアクティビティおよびカテゴリでは、最高レベルの機能のみが 1 を受け取ります。他の場合では、それぞれが機能の最小限のレベルを表す能力を表すため、2 つ以上のレベルのスコアが 1 になります。

これらの画面は、その人の現在のパフォーマンスを具体的に示すのに役立ちます。 したがって、IADL のスコアが高いほど、機能レベルが高いことを表します。 最高スコア = 8 (高機能)、最低スコア = 0 (低機能)。

学習完了まで、平均1年
International physical activity questionnaire (IPARQ)
時間枠:through study completion, an average of 1 year

IPAQ assesses physical activity undertaken across a set of domains. The following values are used for the analysis: Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs.

Low= Individuals who not meet criteria for Categories 2 or 3 are considered to have a 'low' physical activity level.

Moderate= a) 3 or more days of vigorous-intensity activity of at least 20 minutes per day b) 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day c) 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week. High= a) vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week b) 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum Total physical activity of at least 3000 MET-minutes/week.

through study completion, an average of 1 year

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

  • スタディディレクター:Andy Pringle, PhD、University of Derby

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。

一般刊行物

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 (実際)

2021年8月6日

一次修了 (予想される)

2021年10月1日

研究の完了 (予想される)

2021年10月1日

試験登録日

最初に提出

2021年6月6日

QC基準を満たした最初の提出物

2021年6月11日

最初の投稿 (実際)

2021年6月21日

学習記録の更新

投稿された最後の更新 (実際)

2021年8月9日

QC基準を満たした最後の更新が送信されました

2021年8月6日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • UDerby

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

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米国FDA規制医薬品の研究

いいえ

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いいえ

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