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Optimizing Combined Physical and Cognitive Activity in Community-Dwelling Older Adults. (CONSCIOUS)

2026년 6월 1일 업데이트: University Ghent

Determining the Optimal Combination of Physical and Cognitive Activity for Acute Cognitive Benefits in Community-Dwelling Older Adults.

This laboratory-based interventional study aims to determine which combination of physical activity intensity and cognitive activity difficulty yields the greatest acute cognitive benefits in community-dwelling older adults.

The main question it aims to answer is:

- Which combination of physical and cognitive activity results in the greatest short-term improvement in cognitive functioning?

Researchers will compare four different combinations of physical intensity and cognitive task difficulty to determine whether one combination stands out. In addition, the study examines whether these effects differ depending on baseline cardiorespiratory fitness.

Participants will:

  • undergo a preparatory phase in which their cardiorespiratory fitness, individualized physical activity intensity levels, and cognitive activity difficulty levels are established
  • visit the laboratory four times, with one week between visits, to complete each combination of physical and cognitive activity (light vs. moderate physical activity × easy vs. challenging cognitive activity)
  • complete cognitive tests immediately before and after each condition

연구 개요

상세 설명

Recognizing the escalating dementia rates, its profound social and economic consequences and the lack of curative treatments, the World Health Organization (WHO) emphasizes the importance of reducing modifiable risk factors for dementia, as outlined in Action Area 3 of the WHO Global action plan on the public health response to dementia 2017-2025. Previous research suggests that combining physical activity and cognitive activity may produce greater cognitive benefits than either activity alone, but it remains unclear which specific combinations are most effective in older adults. In particular, little is known about how physical activity intensity and cognitive activity difficulty interact, and whether cardiorespiratory fitness influences these effects. The present study addresses this knowledge gap in community-dwelling older adults.

The study is conducted in two consecutive parts. In the preparatory phase, participants attend one laboratory visit. During this phase, baseline screening and descriptive assessments will be performed, cardiorespiratory fitness will beestimated using the 6-Minute Walk Test, individualized physical activity intensity zones will be determined using heart-rate reserve, and cognitive activities will be classified as easy or challenging based on subjective ratings. Participants will also be familiarized with treadmill walking and simultaneous physical and cognitive task performance.

In the fundamental phase, eligible participants will complete four laboratory sessions in randomized order, each involving one combination of physical and cognitive activity: light physical activity with easy cognitive activity, light physical activity with challenging cognitive activity, moderate physical activity with easy cognitive activity, and moderate physical activity with challenging cognitive activity. During each session, participants walk on a treadmill at a prescribed heart-rate-based intensity while simultaneously performing cognitive tasks. Cognitive functioning is assessed immediately before and after each session using three tasks from the CANTAB neuropsychological test battery: a) Multitasking test (MTT), (b) Delayed Matching to Sample (DMS), and (c) Match to Sample Visual Search (MTS), allowing the study to examine the short-term cognitive effects of each physical activity × cognitive activity combination. The overall aim is to identify the optimal combination of simultaneous physical and cognitive activity for acute cognitive benefits in older adults.

연구 유형

중재적

등록 (실제)

53

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Ghent, 벨기에, 9000
        • University Ghent

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Aged 65 years or older
  • Community-dwelling
  • Able to safely walk on a treadmill and complete the 6-Minute Walk Test
  • Sufficient Dutch proficiency to understand study instructions and complete study procedures

Exclusion Criteria:

  • MoCA score < 23
  • Severe cognitive or physical impairment that would hinder participation or understanding of study procedures
  • Use of medication affecting heart rate
  • Any medical condition contraindicating engagement in physical or cognitive activity
  • Severe visual or hearing impairment that would prevent valid participation in the study procedures

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Sequence 1
Participants complete the four experimental conditions in the following order across four separate laboratory visits: C1, C2, C3, and C4. C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
실험적: Sequence 2

Participants complete the four experimental conditions in the following order across four separate laboratory visits: C2, C4, C1, and C3.

C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity.

Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
실험적: Sequence 3

Participants complete the four experimental conditions in the following order across four separate laboratory visits: C3, C1, C4, and C2.

C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity.

Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
실험적: Sequence 4

Participants complete the four experimental conditions in the following order across four separate laboratory visits: C4, C3, C2, and C1.

C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity.

Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Multitasking Test (MTT) performance from pre- to post-condition
기간: Immediately before and 10 minutes after each experimental condition
Change in accuracy and response latency from pre- to post-condition on the Multitasking Test (MTT), assessing executive functioning, cognitive flexibility, and processing speed.
Immediately before and 10 minutes after each experimental condition
Change in Delayed Matching to Sample (DMS) performance from pre- to post-condition
기간: Immediately before and 10 minutes after each experimental condition
Change in accuracy and response latency from pre- to post-condition on the Delayed Matching to Sample (DMS), assessing short-term visual recognition memory.
Immediately before and 10 minutes after each experimental condition
Change in Match to Sample Visual Search (MTS) performance from pre- to post-condition
기간: Immediately before and 10 minutes after each experimental condition
Change in accuracy and response latency from pre- to post-condition on the Match to Sample Visual Search (MTS), assessing visual attention and psychomotor speed.
Immediately before and 10 minutes after each experimental condition

2차 결과 측정

결과 측정
측정값 설명
기간
General impression of each experimental condition
기간: Immediately after each experimental condition, during the 10-minute post-condition interval.
Self-reported general impression of each experimental condition, rated on a 0-10 scale, where 0 indicates "not good at all" and 10 indicates "very good."
Immediately after each experimental condition, during the 10-minute post-condition interval.
Perceived feasibility of each experimental condition
기간: Immediately after each experimental condition, during the 10-minute post-condition interval.
Self-reported feasibility of each experimental condition, rated on a 0-10 scale in response to the statement "I feel capable of doing this session," where higher scores indicate greater perceived feasibility.
Immediately after each experimental condition, during the 10-minute post-condition interval.
Enjoyment of each experimental condition
기간: Immediately after each experimental condition, during the 10-minute post-condition interval.
Self-reported enjoyment of each experimental condition, rated on a 0-10 scale in response to the statement "I enjoyed this session," where higher scores indicate greater enjoyment.
Immediately after each experimental condition, during the 10-minute post-condition interval.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Greet Cardon, Prof. Dr., University Ghent

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 2일

기본 완료 (실제)

2026년 5월 13일

연구 완료 (실제)

2026년 5월 13일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CONSCIOUS - ONZ-2025-0282

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data collected during the study will be made available to other researchers. The exact dataset(s), supporting documents, timing, and access procedures will be specified after completion of the main analyses and publication of the primary study results.

IPD 공유 기간

De-identified individual participant data will become available after publication of the primary study results and are expected to remain available indefinitely in an institutional or open research repository.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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