NCT07443189

Brief Summary

This project investigates the relative benefits of regular physical activity and bilingualism for ameliorating cognitive decline in healthy ageing, with a particular focus on language function. The randomized intervention component tests whether improving fitness via a home-based HIIT program leads to changes in fitness and related cognitive/language outcomes in older adults.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

February 17, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

Fitnesshigh-intensity interval traininghome-based exerciseHIITbilingualismlanguage functionVO2peak

Outcome Measures

Primary Outcomes (11)

  • Aerobic fitness - VO₂peak

    Direct measurement of maximal oxygen uptake during a standardized progressive treadmill walking protocol to volitional fatigue. Participants complete 2-7 min self-paced level walking before the test. The test starts at 3.8 km/h with 4% incline; after a 4-min warm-up/stabilization, incline increases 3% every 4 min until blood lactate is 2.1 mmol/L above baseline, then incline increases 2% per minute up to 20%, followed by speed increases of 0.5 km/h per minute to exhaustion. VO₂peak is defined as the average of the highest 30-s VO₂ values. Test validity requires RER ≥ 1.10 or Borg ≥ 17.

    Baseline; 26 weeks (post-intervention)

  • Language function - Tip-of-the-tongue (TOT) task

    Participants read definitions and attempt to name the target word (e.g., "A young swan" → "cygnet"). After each item they indicate Know, Don't Know, or Tip-of-the-tongue. The behavioral task includes 60 items (30 cognates; 30 non-cognates). Separate stimulus sets are used for English vs Norwegian, and for pre- vs post-intervention testing. Outcomes include probability of Know and TOT vs Don't Know (knowledge) and TOT vs Know (TOT probability).

    Baseline; 26 weeks (post-intervention)

  • Language function - sentence production (speeded picture description)

    Speeded picture description to elicit phrases varying in type (coordinate vs prepositional clauses) and complexity (simple vs adjective-modified phrases). Stimuli comprise 20 image pairs, each appearing once in each of four conditions (within-items; within-subject). Outcomes include speech onset latency (RT) for correct responses and accuracy (correct clause produced). Separate stimulus sets are used for English pre, English post, Norwegian pre, and Norwegian post.

    Baseline; 26 weeks (post-intervention)

  • Language function - sentence comprehension (auditory word monitoring)

    Participants make a speeded button press when they hear a pre-specified target word embedded in auditory input. Targets appear in unstructured lists, meaningful sentences with low target probability, and meaningful sentences with high target probability. Each stimulus set contains 60 items arranged across lists using a Latin square design. Outcome is reaction time measured from speech onset to button press for correct trials (and accuracy as applicable). Separate sets are used for English pre, English post, Norwegian pre, and Norwegian post.

    Baseline; 26 weeks (post-intervention)

  • Language function - discourse production (free picture description)

    Participants describe one of four matched scenes inspired by the "cookie theft" picture (updated to include more objects/actions and less stereotyped roles). Primary outcome is speech duration (time speaking). Additional planned outcomes may include language complexity (e.g., mean phrase length, mean lexical frequency) and fluency (e.g., syllables per second, pausing-to-speech ratio). Scene presentation is counterbalanced to minimize repetition across sessions where applicable.

    Baseline; 26 weeks (post-intervention)

  • Language control - language switching (bilinguals only; cued picture naming)

    Bilingual participants name pictures of common objects in L1 (Norwegian) or L2 (English) following a cue. 24 items appear across eight blocks: two English-only and two Norwegian-only blocks (single-language), plus four mixed blocks containing switch (L1↔L2) and stay trials. Two matched stimulus sets (pre and post) are used; order is counterbalanced. Outcomes include switching score (RT difference switch vs stay trials) and switching cost (RT difference switching vs non-switching blocks), plus accuracy.

    Baseline; 26 weeks (post-intervention)

  • Cognitive function - processing speed (letter comparison)

    Same/different judgments for two letter strings presented top/bottom; string length varies from 3 to 6 letters, total 48 trials. Outcomes are reaction time and accuracy for correct responses.

    Baseline; 26 weeks (post-intervention)

  • Cognitive function - working memory (n-back)

    1-back and 2-back continuous performance task with 120 trials total (60 1-back; 60 2-back). Outcomes are reaction time and accuracy; incorrect includes misses/omissions as specified.

    Baseline; 26 weeks (post-intervention)

  • Cognitive function - working memory (digit span)

    Digits presented with 1-second inter-stimulus interval. Sequence length starts at 3 digits and increases up to 12. Each length is presented three times; participants must recall 2/3 correctly to continue. Task stops when criterion is not met. Outcome is maximum correctly recalled span (maximum 30 trials).

    Baseline; 26 weeks (post-intervention)

  • Cognitive function - attention/executive control (Attention Network Task; ANT)

    Combined Posner cueing and flanker paradigm. Participants indicate direction of a central arrow flanked by congruent or incongruent arrows; cues indicate target location (top/bottom) after warning signal. 96 trials per block, 3 blocks total. Outcomes are ANT network indices: alerting (no cue RT - cue RT), orienting (center cue RT - spatial cue RT), and executive control (incongruent RT - congruent RT), computed for correct responses.

    Baseline; 26 weeks (post-intervention)

  • Cognitive function - task switching (colour-shape switching)

    Four blocks: first/last are single-task ("solid") blocks (colour-only or shape-only), middle two are mixed blocks with switch/stay trials. Total 144 trials. Outcomes include RT and accuracy, plus local and global switch costs.

    Baseline; 26 weeks (post-intervention)

Secondary Outcomes (17)

  • Aerobic fitness - blood lactate concentration

    Baseline; 26 weeks (post-intervention)

  • Physical function - handgrip strength

    Baseline; 26 weeks (post-intervention)

  • Physical function - 30-second chair stand

    Baseline; 26 weeks (post-intervention)

  • Physical function - chair sit-and-reach (hamstring flexibility)

    Baseline; 26 weeks (post-intervention)

  • Physical function - back scratch (shoulder flexibility)

    Baseline; 26 weeks (post-intervention)

  • +12 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will complete a 26-week home-based HIIT program comprising simple circuit training once per week and interval training twice per week. A 26-week dose will be targeted; if interruptions occur (e.g., illness, travel), the intervention period will be extended to ensure completion of 26 weeks of exercise sessions. The first four weeks will constitute a familiarization period with sub-maximal sessions, training equipment familiarization (Polar Unite watch and Polar H9 chest sensor), and instructional videos. Subsequent sessions will target high intensity (≥80% of HRpeak). Training will be guided by a personal exercise coach via emails, phone calls, and face-to-face meetings once weekly during the familiarization period and monthly thereafter. Participants will use a Polar Unite watch and Polar H9 chest sensor; the watch will be pre-programmed to display %HRpeak in real time during sessions. Exercise data will be extracted using Polar Flow software.

Other: Home-Based HIIT

Control group

NO INTERVENTION

Control participants will be instructed to maintain their usual lifestyles without significant changes to physical activity or dietary habits.

Interventions

Participants will complete a 26-week home-based HIIT program comprising simple circuit training once per week and interval training twice per week. A 26-week dose will be targeted; if interruptions occur (e.g., illness, travel), the intervention period will be extended to ensure completion of 26 weeks of exercise sessions. The first four weeks will constitute a familiarization period with sub-maximal sessions, training equipment familiarization (Polar Unite watch and Polar H9 chest sensor), and instructional videos. Subsequent sessions will target high intensity (≥80% of HRpeak). Training will be guided by a personal exercise coach via emails, phone calls, and face-to-face meetings once weekly during the familiarization period and monthly thereafter. Participants will use a Polar Unite watch and Polar H9 chest sensor; the watch will be pre-programmed to display %HRpeak in real time during sessions. Exercise data will be extracted using Polar Flow software.

Also known as: Home-based high intensity training
Exercise

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smokers for at least 5 years prior to enrollment.
  • Normal or corrected-to-normal vision and hearing.
  • No diagnosed language impairments (e.g., dyslexia, stuttering).
  • No illness or disease that would prevent safe participation in high-intensity interval training (HIIT).
  • Self-reported not meeting global physical activity recommendations (i.e., \<150 minutes/week of moderate-intensity physical activity).
  • Norway only: Written health certificate from the participant's general practitioner confirming eligibility for participation.

You may not qualify if:

  • Any cardiovascular, metabolic, respiratory, neurological, kidney, liver, or cancer disease that would prevent safe participation in HIIT.
  • United Kingdom only: Severe electrocardiogram abnormalities (e.g., ST depression, long QT, heart block, wide QRS).
  • United Kingdom only: Elevated blood pressure at screening (systolic \>160 mmHg and/or diastolic \>90 mmHg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Agder

Kristiansand, 4614, Norway

Location

University of Birmingham

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Cognitive DysfunctionLanguage

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 2, 2026

Study Start

September 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results will be reported via OSF Storage.

More information

Locations