Simultaneous Recumbent Cycling and Cognitive Training

Conditions

• Delirium
• Impaired Cognition

Eligibility Criteria

Sex

ALL

Age

45 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Simultaneous Cycle/Cognitive Training — BEHAVIORAL
  Two weeks after discharge from the hospital the intervention group will complete recumbent cycle for 1 hour, 2x/wk. for 12 weeks (24 sessions). 10-minute cycle warm-up, 40-minute simultaneous cycling and cognitive training, 10-minute cool down. Cycling based on provider prescription and progression of physical recovery. Cognitive training program from Posit Science, Brain HQ (TM) progressive level of difficulty. Total duration of 60 minutes.

Study Details

Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts quality of life (QOL) long after hospital discharge. The average age of ICU patients is 52 years. These middle-age (MA) ICU survivors need cognitive interventions that are well planned, accessible, and effective to improve cognition and prevent accelerated decline so they can resume their previous QOL and enter older age with optimized cognitive function. Physical exercise and cognitive training independently improve cognition and emerging evidence indicates that combining these two approaches produces even greater effects on cognition. Community-based rehabilitation centers are accessible for MAICU survivors to engage in physical activity; cognitive training could easily be added. Approaches in which a patient engages in physical exercise and cognitive training concurrently is an understudied intervention for all ICU survivors, especially those who are middle-aged. Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU survivors who experienced at least one delirium episode during their ICU stay. Feasibility will be determined by systematically evaluating research team training, participant recruitment, randomization, implementation, and intervention fidelity. Acceptability will be evaluated via a satisfaction, preferences, burden, and participant-suggested improvements survey. The SRCCT effect sizes will be calculated comparing multiple data point cognition scores between an SRCCT group and a usual care control group. Upon completion, investigators expect to understand the feasibility and acceptability of the SRCCT delivered in community-based rehabilitation centers, and the combined effect of SRCCT on cognition and QOL for middle-aged ICU survivors who experienced an episode of ICU delirium. The hypothesis is that study participants who engage in physical exercise and cognitive training concurrently will have a greater improvement in cognition and QOL than physical exercise training alone.

Key Dates

Start date

Dec 3, 2024

Status verified

Dec 2024

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Simultaneous Cycle/Cognitive Training
  After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.
• No Intervention: Usual Care
  After discharge from the hospital the group will complete baseline activies.

Primary Outcome Measure

Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey [ Time Frame: At study completion, approximately 36 weeks. ]

Central Contacts

• Rita S Lasiter, PhD
  816-235-6766
  [email protected]
• Matthew S Chrisman, PhD
  816-235-5709
  [email protected]

Locations (1)

Find similar trials in Kansas City, MO

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