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Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.

2026年7月28日 更新者:JAVIER FERNÁNDEZ-ORTEGA、Universidad de Granada
This study evaluates the effects of a community-based multicomponent exercise program on physical function, frailty, and sarcopenia in older adults living in the municipality of Santoña (Cantabria, Spain). The exercise program is organized and delivered by the Santoña Town Council as part of its public health services for older residents and is not created for research purposes; it will continue regardless of the outcome of this study. Researchers are only evaluating participants who voluntarily agree to be assessed before and after each 36-week cycle of the program, over four consecutive academic years (2026-2030). The main question this study aims to answer is whether continued participation in this real-world, community-based multicomponent exercise program (based on the Vivifrail model) leads to meaningful improvements in physical function, muscle strength, and cardiorespiratory capacity, and helps reverse indicators of frailty and sarcopenia in independent, community-dwelling older adults. Participants will complete functional and physical tests, including balance, gait speed, chair-stand performance, handgrip strength, and a 6-minute walk test, at the start and end of each 36-week exercise cycle. No blood or biological samples will be collected.

調査の概要

詳細な説明

Most of the existing evidence on the benefits of multicomponent exercise for reversing frailty and sarcopenia in older adults comes from lab-based clinical trials conducted in highly controlled hospital or laboratory settings. While these studies have strong internal validity, they often lack ecological validity, meaning they do not reflect the real-world conditions, barriers, and adherence dynamics of community-based programs. There is therefore a public health need to evaluate whether the efficacy demonstrated in controlled settings translates into real, sustainable effectiveness when delivered through existing municipal, real-world programs.

This study evaluates a pre-existing, independently run community exercise program organized by the Santoña Town Council (Cantabria, Spain) for older adults referred through local health centers. The program has been running for several years and will continue to be delivered by the Town Council regardless of this study's outcome. The scope of this research is limited to the scientific evaluation of participants' physical and functional status before and after their participation in the program; the research team has no role in designing, modifying, or delivering the exercise intervention itself.

Design: This is a quasi-experimental, single-group, repeated-measures (pre-post) study. A passive control group was not included, as the community health-promotion nature of the program makes it inappropriate to withhold access to exercise and its benefits from eligible older residents. Each participant serves as their own control, comparing baseline and post-intervention measures.

Intervention being evaluated: The municipal exercise program follows a 36-week multicomponent format addressing strength, balance, endurance, and flexibility, structured according to the FITT-VP principles of the Vivifrail model (Izquierdo, 2019). Sessions are supervised by qualified exercise professionals who individualize training loads. The research team is not modifying this program in any way; researchers are solely adding an assessment protocol before and after each 36-week cycle.

Recruitment and timeframe: Recruitment will take place annually over four consecutive academic years (2026/2027 to 2029/2030), with an estimated 60 participants recruited per cohort, for a cumulative total of approximately 240 participants across the study period.

Outcome assessment: At baseline (week 0) and at the end of each 36-week cycle (week 36), participants will undergo: basic anthropometric measurements (weight, height, waist circumference); a self-perceived fitness questionnaire (IFIS); the Short Physical Performance Battery (SPPB), assessing balance, 4-meter gait speed, and 5-times chair-stand performance; handgrip strength via isometric dynamometry; the 30-Second Chair Stand Test as an additional measure of lower-limb strength; and the 6-Minute Walk Test to assess cardiorespiratory capacity. No blood draws, biopsies, or other biological samples are collected at any point.

Safety considerations: Because participants are community-dwelling older adults rather than clinical patients, the assessment protocol does not interfere with any necessary medical treatment, and no placebo is used. Expected adverse effects are mild and transient (e.g., delayed-onset muscle soreness, general fatigue, occasional mild joint discomfort), with a low inherent risk of musculoskeletal injury or falls associated with physical exertion. All sessions are supervised by qualified exercise professionals, loads are individualized, and an adverse event monitoring and reporting protocol is in place. Participants are covered by the Santoña Town Council's civil liability insurance for municipal activities and facilities.

Setting: Data collection and the exercise program take place at municipal sports facilities and community centers made available by the Santoña Town Council under an institutional collaboration agreement. Scientific direction, statistical analysis, and custody of anonymized data are centrally managed by the research team at the University of Granada (UGR).

研究の種類

介入

入学 (推定)

300

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。

研究連絡先

  • 名前:JAVIER Fernández-Ortega, PhD Student, Sports Science
  • 電話番号:+34 958246635
  • メール:fernandezortegaj@ugr.es

研究連絡先のバックアップ

  • 名前:Andrés B. Fernández-Revelles, Sport Sciences
  • メール:abfr@ugr.es

研究場所

    • Andalusia
      • Granada、Andalusia、スペイン、18004
        • Faculty of Sports Science
        • コンタクト:
          • Andrés B. Fernández-Revelles, Principal Investigator, Sport Science
          • 電話番号:+34 958246635
          • メール:abfr@ugr.es

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

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 65 years or older
  • Independent, community-dwelling (not institutionalized)
  • Barthel Index score ≥ 90 points (no significant disability)
  • Timed Up and Go (TUG) test ≥ 10 seconds
  • Short Physical Performance Battery (SPPB) score below 12 points (indicating possible frailty)
  • Fall risk indicated by at least one of the following: one fall in the past year requiring assistance, more than one fall without assistance, TUG > 20 seconds, or gait speed over 6 meters > 7.50 seconds
  • Reduced grip strength: below 27 kg (men) or below 16 kg (women), or more than 15 seconds to complete 5 chair stands
  • Voluntary signed informed consent

Exclusion Criteria:

  • Terminal illness
  • Residing in a nursing home
  • Diagnosed with, or under investigation for, moderate to severe cognitive impairment
  • Unstable cardiovascular disease
  • Acute infectious disease
  • Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 110 mmHg)
  • Uncontrolled diabetes
  • Advanced organ failure
  • Disabling musculoskeletal condition

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:Community Multicomponent Exercise Program
Participants aged 65 and older meeting the inclusion criteria take part in the pre-existing 36-week multicomponent exercise program delivered by the Santoña Town Council. Functional and physical assessments are performed at baseline (week 0) and at the end of each 36-week cycle (week 36), across four consecutive academic years. Each participant serves as their own control.
A 36-week community-based multicomponent exercise program addressing strength, balance, endurance, and flexibility, structured according to the Vivifrail FITT-VP model. Sessions are delivered by qualified exercise professionals as part of the Santoña Town Council's existing public health services, independently of this study.

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
Short Physical Performance Battery (SPPB) score
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Composite score assessing lower-extremity physical function through three components - standing balance, 4-meter gait speed, and time to complete five repeated chair stands. Total score ranges from 0 to 12, with lower scores indicating greater physical frailty.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

二次結果の測定

結果測定
メジャーの説明
時間枠
Handgrip strength
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
30-Second Chair Stand Test
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Number of full stands completed from a seated position in 30 seconds, used as a measure of lower-limb muscular strength and endurance.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
6-Minute Walk Test (6MWT) distance
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Total distance (in meters) walked in 6 minutes, used as a measure of cardiorespiratory capacity and functional exercise tolerance.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Body weight and Body Mass Index (BMI)
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Body weight (kg) and BMI, calculated from measured weight and height, assessed as basic anthropometric indicators.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Waist circumference
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Waist circumference (cm), used as an indicator of central adiposity.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Self-perceived fitness (International Fitness Scale, IFIS)
時間枠:Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Self-reported perception of overall physical fitness and its four specific dimensions (cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) assessed using the International Fitness Scale (IFIS). The scale consists of 5 main items, each evaluated on a 5-point Likert scale ranging from 1 ("very poor") to 5 ("very good"). Each individual item score ranges from 1 to 5, where higher scores indicate better self-perceived physical fitness.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

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:Andrés B. Fernández-Revelles, Sport Science、Universidad de Granada

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 (推定)

2026年10月1日

一次修了 (推定)

2030年6月1日

研究の完了 (推定)

2030年7月31日

試験登録日

最初に提出

2026年7月23日

QC基準を満たした最初の提出物

2026年7月23日

最初の投稿 (実際)

2026年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

De-identified individual participant data collected during the study (anthropometric, functional, and cardiorespiratory outcome measures) will be made available, along with an accompanying data dictionary describing all variables collected.

IPD 共有時間枠

Beginning after publication of the main results article associated with each cohort, with no specified end date.

IPD 共有アクセス基準

Data will be made available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author. Requests should specify the intended use of the data and will be reviewed by the research team.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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

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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