Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care (FRAIL+AP)
Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial
Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited.
This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system.
The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.
調査の概要
詳細な説明
Frailty is a prevalent geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes, including falls, disability, hospitalization, institutionalization, and mortality. The Canary Islands have one of the highest rates of frailty and pre-frailty among community-dwelling older adults in Spain, highlighting the need for effective and scalable interventions within primary care settings.
Comprehensive Geriatric Assessment (CGA) is considered the gold standard for identifying multidimensional health needs in older adults and for guiding individualized care plans. In parallel, multicomponent exercise programs incorporating strength, balance, endurance, and flexibility training have demonstrated effectiveness in improving physical function and reducing frailty-related impairments. However, challenges remain regarding the implementation of these interventions in routine primary care practice.
The FRAIL+AP study is a multicenter, randomized controlled trial designed to evaluate the clinical efficacy of a primary care-based intervention combining Comprehensive Geriatric Assessment, health education, and a supervised multicomponent exercise program in frail and pre-frail older adults. The intervention also incorporates visual-spatial gait retraining using the Tapiz Fisior system, a structured floor-grid tool aimed at improving gait control, balance, coordination, and fall prevention.
A total of 200 community-dwelling adults aged 70 years and older will be recruited from five primary care centers in Tenerife, Spain. Eligible participants will be randomly allocated in a 1:1 ratio to either the intervention group or a control group receiving usual care. The intervention will last 12 weeks and will consist of supervised and home-based exercise sessions, together with educational activities focused on healthy lifestyles, nutrition, frailty awareness, and fall prevention.
Primary outcomes include changes in frailty status assessed by the FRAIL Scale and physical performance measured using the Short Physical Performance Battery (SPPB). Secondary outcomes include incidence of falls, pain perception, mood, functional independence, nutritional status, handgrip strength, healthcare resource utilization, and comorbidity measures. Outcomes will be assessed at baseline and one week after completion of the intervention by blinded evaluators.
The study aims to determine whether the FRAIL+AP protocol can improve physical performance, reduce frailty, and support healthy aging through an integrated and scalable model that can be implemented within routine primary care services.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ángel Moisés Reyes Abreu, Registered Nurse
- 電話番号：+34922474058
- メール：enf.enlacetacoronte@gmail.com
研究連絡先のバックアップ
- 名前：Alberto Bermejo Franco, PhD (Physiotherapy)
- 電話番号：+34656932144
- メール：alberto.bermejo@universidadeuropea.es
研究場所
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Santa Cruz de Tenerife
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Tacoronte、Santa Cruz de Tenerife、スペイン、38350
- 募集
- Centro de Salud Tacoronte
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コンタクト：
- Ángel Moisés Reyes Abreu, Registered Nurse
- 電話番号：+34922474058
- メール：enf.enlacetacoronte@gmail.com
-
コンタクト：
- Alberto Bermejo Franco, PhD (Physiotherapy)
- 電話番号：+34656932144
- メール：alberto.bermejo@universidadeuropea.es
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副調査官：
- Carlos Eusebio Esparza Ferrera, Physiotherapist
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Community-dwelling adults aged 70 years or older.
- Ability and willingness to provide written informed consent.
- Medical clearance to participate in low-to-moderate intensity physical exercise.
- Presence of frailty or pre-frailty defined by meeting at least two of the following criteria:
- Functional independence sufficient to participate in the intervention (Barthel Index >80.
- FRAIL Scale score ≥ 1.
- Short Physical Performance Battery (SPPB) score < 10.
- Gait speed < 0.8 m/s.
- Timed Up and Go (TUG) test > 12 seconds.
- Registered at one of the participating primary care centers.
Exclusion Criteria:
- Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis.
- Severe cognitive impairment preventing comprehension of study procedures or exercise instructions.
- Severe psychiatric disorders interfering with participation.
- Absence of a legally authorized representative when required.
- Severe uncontrolled behavioral disturbances.
- Any acute or chronic medical condition considered by the investigators to make participation unsafe.
Discontinuation Criteria:
- Failure to attend the initial mandatory health education workshop.
- Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions.
- Development of an acute medical condition that results in a temporary or permanent contraindication to physical activity.
- Participant withdrawal of informed consent.
研究計画
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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実験的：FRAIL+AP Program
Participants receive a 12-week intervention consisting of a Comprehensive Geriatric Assessment (CGA), health education, and a multicomponent exercise program combining strength, balance, mobility, flexibility, and visual-spatial gait retraining using the Tapiz Fisior system.
The intervention includes one supervised session and one home-based session per week.
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A 12-week multicomponent intervention including Comprehensive Geriatric Assessment, health education, strength training, balance exercises, mobility training, flexibility exercises, and visual-spatial gait retraining using the Tapiz Fisior system.
Participants attend one supervised session and perform one home-based session per week.
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アクティブコンパレータ：Usual Care
Participants receive standard primary care follow-up according to the Canary Health Service guidelines, including routine medical care and general lifestyle recommendations, without participation in the FRAIL+AP structured exercise program.
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Standard primary care management according to regional healthcare guidelines without structured exercise intervention.
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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 frailty status measured by the FRAIL Scale
時間枠：Baseline and 12 weeks
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Change in FRAIL Scale score from baseline to 12 weeks.
The FRAIL Scale ranges from 0 to 5, with higher scores indicating greater frailty (0 = robust, 1-2 = pre-frail, 3-5 = frail).
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Baseline and 12 weeks
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Change in physical performance measured by the Short Physical Performance Battery (SPPB)
時間枠：Baseline and 12 weeks
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Change in the total Short Physical Performance Battery (SPPB) score from baseline to 12 weeks.
The SPPB total score ranges from 0 to 12, with higher scores indicating better physical performance.
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Baseline and 12 weeks
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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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Incidence of Falls
時間枠：Baseline and 12 weeks
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Number of falls recorded during the study period using participant diaries and verified through electronic medical records.
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Baseline and 12 weeks
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Handgrip Strength
時間枠：Baseline and 12 weeks
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Change in upper-limb muscle strength measured by handgrip dynamometry.
The highest value obtained from standardized testing procedures will be recorded.
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Baseline and 12 weeks
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Comorbidity Burden
時間枠：Baseline and 12 weeks
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Change in clinical comorbidity status assessed using the Charlson Comorbidity Index.
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Baseline and 12 weeks
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Healthcare Resource Utilization
時間枠：Baseline and 12 weeks
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Healthcare utilization assessed through review of electronic medical records, including primary care visits, emergency department attendance, hospital admissions, and other healthcare contacts during the study period.
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Baseline and 12 weeks
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Musculoskeletal Pain Intensity
時間枠：Baseline and 12 weeks
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Change in musculoskeletal pain intensity measured using the Numeric Rating Scale (NRS).
The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
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Baseline and 12 weeks
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Mood and Affective Status
時間枠：Baseline and 12 weeks
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Change in depressive symptoms measured using the 15-item Geriatric Depression Scale (GDS-15).
The GDS-15 total score ranges from 0 to 15, with higher scores indicating greater depressive symptomatology.
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Baseline and 12 weeks
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Functional Independence
時間枠：Baseline and 12 weeks
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Change in functional independence measured using the Barthel Index.
The Barthel Index total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
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Baseline and 12 weeks
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Nutritional Status
時間枠：Baseline and 12 weeks
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Change in nutritional status measured using the Mini Nutritional Assessment (MNA).
The MNA total score ranges from 0 to 30, with higher scores indicating better nutritional status.
Scores <17 indicate malnutrition, 17-23.5 indicate risk of malnutrition, and 24-30 indicate normal nutritional status.
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Baseline and 12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ángel Moisés Reyes Abreu, Registered Nurse、Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
- スタディディレクター：Alberto Bermejo Franco, PhD (Physiotherapy)、Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)
出版物と役立つリンク
一般刊行物
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.
- Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
- Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
- Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
- Beard JR, Officer A, de Carvalho IA, Sadana R, Pot AM, Michel JP, Lloyd-Sherlock P, Epping-Jordan JE, Peeters GMEEG, Mahanani WR, Thiyagarajan JA, Chatterji S. The World report on ageing and health: a policy framework for healthy ageing. Lancet. 2016 May 21;387(10033):2145-2154. doi: 10.1016/S0140-6736(15)00516-4. Epub 2015 Oct 29.
- Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
- Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.
- Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.
- Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- CHUC_2026_19
- PIFIISC 25/28 (その他の助成金/資金番号：Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC))
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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