Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

A fizikai tartalékok növelése a reziliencia előmozdítása érdekében fizikailag törékeny időseknél (MRI exercise)

2026. szeptember 22. frissítette: HSU Chun Liang, The Hong Kong Polytechnic University

A fizikai tartalékok növelése a kognitív és fizikai ellenállóképesség előmozdítására fizikailag törékeny időseknél: Egy 3 hónapos randomizált kontrollált vizsgálat

The goal of this clinical trial is to assess the efficacy of combined aerobic and resistance training in enhancing physical reserve in older adults with physical frailty. Investigator contend that enhanced physical reserve will enable preservation of cognitive and physical function. The main questions aims to answer are: (1) Compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)?

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

Objectives: (1) To compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)? (4) What is the association between exercise, neural network, and physical reserve? Hypotheses: Investigator hypothesize that (1) compared to participants randomly assigned to the CON, participants randomly assigned to the 3-month ATRT will show significantly enhanced physical reserve. (2) compared with participants randomly assigned to CON, participants randomly assigned to ATRT will show reduction in Dorsal Attention Network connectivity. (3) Enhanced physical reserve will moderate the negative association between WMH and Trail Making Test performance, as well as WMH and Short Physical Performance Battery performance. (4) combined aerobic and resistance training will enhance physical reserve via a mediated relationship with reduced Dorsal Attention Network connectivity.

Design and subjects: A randomized controlled trial involving 224 community-dwelling older adults with physical frailty Study instruments: Magnetic resonance imaging Interventions: The designed exercise training will be progressive and moderate in intensity. Participants randomized to the ATRT group will undergo a 3-month (i.e., 13-weeks) four-sessions-per-week, 60-minute-per-session exercise with a 10-minute warm-up, 40-minute of moderate intensity exercise training, and 10-minute cool-down. There will be a total of 52 exercise sessions with a 1:3 research staffs (i.e., instructor and assistants) to study participants ratio. To promote participant safety, investigator will limit each session to 12 study participants. To ensure fidelity of the intervention across time, a detailed manual of procedures for each experimental group will be developed and used for staff training.

Data analysis: All analyses will follow the intent to treat principle. The principle investigator will lead all analyses with support from collaborators on WMH quantification and structural MRI analyses. The intention-to-treat analysis will be conducted with multiple imputation followed by a complete-case analysis. Statistical significance for all analyses will be defined at α < 0.05.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

224

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 0000000
        • Toborzás
        • The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

60 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  1. are community-dwelling (i.e., not residing in a nursing home or extended care unit) ;
  2. scored < 9/12 on the SPPB;
  3. scored >18/30 on the MoCA;
  4. are able to walk independently; use of walking aid is acceptable;
  5. are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire Plus33 and confirmed by their physician;
  6. have internet at home; and
  7. are able to provide written informed consent.

Exclusion Criteria:

  1. diagnosed with dementia or stroke;
  2. self-report engaging in strength and balance training exercises > two-times-per-week in the 3 months prior to screening;
  3. unable to understand, speak, and read Cantonese/Chinese/English proficiently; and
  4. contraindications for MRI such as MRI-incompatible implants.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Aerobic and resistance training

Participants will complete two aerobic training sessions and two resistance training sessions per week for a total of four exercise training sessions each week lasting for 3-month (i.e., 13-weeks). Aerobic exercise intensity will be tracked through heart-rate monitors with an age-specific targeted heart-rate-reserve initially set at 50% and progressively increased by 5% weekly until 70% heart-rate-reserve is reached in Week-5, then it will be sustained for the remainder of the trial. The first four weeks of the resistance training program will emphasize on assisting the study participants in gaining familiarity with proper technique. The intensity of the resistance training stimulus will be set to a weight where the participants can complete two sets of 10-15 repetitions, then progressed from 45% to 85% of predicted 1-repetition-maximum determined at Week-4 using the 8-rep maximum test. The 8-rep maximum test is rrepeated every 4 weeks to ensure the exercise intensity is maintained
Viselkedési: Aerobic and resistance training

The aerobic training sessions will involve standardized sets of stationary training, including on-spot jogging, burpees, aerobic steppers, agility ladders, and non-contact boxing. Each participant will rotate through the stations within the 40-minute training period, with one-minute of rest breaks in-between each station. A 20-point rate-of-perceived exertion will be used to monitor participant status during training with a target rate-of-perceived exertion of 16-17.

The resistance training sessions will involve utilizing free weights and resistance bands to stimulate muscle strength. The set of movements include triceps extension, dumbbell bicep curls, seated overhead dumbbell press, bent-over dumbbell row, wall squats, standing calf raises, wall push-ups.
Placebo Comparator: Usual care

Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study.

Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately.
Viselkedési: Usual Care

Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study.

Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
30 seconds sit-to-stand test
Időkeret: Baseline and 3 months

Mobility
Baseline and 3 months
Quantification of physical reserve
Időkeret: Baseline and 3 months

Physical reserve will be operationally defined as the unexplained residual variance in 30-second Sit-to-Stand Test after accounting for the effects of age, cognitive capacity, and brain structural integrity.
Baseline and 3 months
Alzheimer's Disease Assessment Scale-Cognitive-13
Időkeret: Baseline and 3 months

Cognitive capacity will be assessed by the Alzheimer's Disease Assessment Scale-Cognitive-13. It measures memory, language, praxis, attention, and executive function, with scores ranging from 0 to 85; higher scores indicate greater cognitive impairment.
Baseline and 3 months
Total hippocampal volume
Időkeret: Baseline and 3 months

Total hippocampal volume will be selected to reflect brain structural integrity
Baseline and 3 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Trail Making Test
Időkeret: Baseline and 3 months

The Trail Making Test will comprise Part A and Part B. In Part A, participants are instructed to connect numbers in sequential order (e.g., drawing a line from 1 to 2, 2 to 3, 3 to 4, etc.) while being timed. In Part B, participants are instructed to connect, in order, 25 encircled numbers and letters alternately (e.g., 1-A-2-B-3-C) while being timed. A longer time represents worse executive function.
Baseline and 3 months
Resting state functional connectivity
Időkeret: Baseline and 3 months

Functional MRI will be used to measure resting state functional connectivity
Baseline and 3 months
Education
Időkeret: Baseline and 3 months

Years of education of participants will be recorded
Baseline and 3 months
Physical Activity Scale for the EAlderly
Időkeret: Baseline and 3 months

Physical activity will be assessed by the Physical Activity Scale for the Elderly. Higher scores represent better physical activity.
Baseline and 3 months
Body mass index
Időkeret: Baseline and 3 months

Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Baseline and 3 months
Pictorial Fit-Frail Scale
Időkeret: Baseline and 3 months

Physical frailty will be assessed by the Pictorial Fit-Frail Scale. It involves 14 domains, with scores ranging from 0 to 43; higher scores indicate severely frail.
Baseline and 3 months
Short Physical Performance Battery
Időkeret: Baseline and 3 months

Physical frailty will be measured by the Short Physical Performance Battery. It measures balance, walking, and sit to stand, with scores ranging from 0 to 12; higher scores indicate greater mobility.
Baseline and 3 months
The Montreal Cognitive Assessment
Időkeret: Baseline and 3 months

General cognitive function will be assessed by the Montreal Cognitive Assessment. It measures memory, language, visuospatial, attention, and abstract reasoning, with scores ranging from 0 to 30; higher scores indicate greater general cognition.
Baseline and 3 months
Functional Comorbidity Index
Időkeret: Baselin and 3 months

Total number of comorbid conditions will be assessed through the Functional Comorbidity Index , with a maximum score of 18. A lower score indicates fewer comorbidities.
Baselin and 3 months
Sleep duration
Időkeret: Baselin and 3 months

Sleep duration will be recorded in hours over the last 24 hours and the last 7 days.
Baselin and 3 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

The Hong Kong Polytechnic University

Együttműködők

University of British Columbia

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. január 19.

Elsődleges befejezés (Becsült)

2028. december 31.

A tanulmány befejezése (Becsült)

2029. március 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. március 23.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. március 30.

Első közzététel (Tényleges)

2026. április 7.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 25.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 22.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • HSEARS20250709003
  • 25603525 (Egyéb támogatási/finanszírozási szám: Research Grants Council, Hong Kong SAR)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

Investigators will create a de-identified dataset to share at the time of publishing the primary results of our trial or within 9 months of database lock, whichever comes first. The data to be shared include but not limited to: de-identified instrument item and total scores of primary and secondary outcomes; de-identified exercise session report data

IPD megosztási időkeret

Dec 2028

IPD-megosztási hozzáférési feltételek

a commitment to using the data only for research purposes and not to identify an individual participant; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; all data sharing requests must be reviewed and approved by the PI.

Az IPD megosztását támogató információ típusa

  • STUDY_PROTOCOL
  • NEDV

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel