Influence of a structured aerobic physical exercise intervention on cognitive function, emotional state and quality of life in traumatic brain injury patients in the chronic stage

Aerobic exercise and cognitive function in chronic severe traumatic brain injury survivors: a within-subject A-B-A intervention study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17487462

Enrollment

Registered

2024-07-11

Start date

2019-07-01

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe traumatic brain injury at the chronic stage Injury, Occupational Diseases, Poisoning

Interventions

Aerobic physical exercise, 20 weeks, 3 sessions per week, 30 minutes per session. Three phases (20 weeks each) were designed as follows: Phase A1: Ongoing individually tailored outpatient neurorehabil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A severe TBI, defined as a score between 3 and 8 on the Glasgow Comma Scale at the time of injury 2. Age range: 18 to 65 years old 3. A minimum of 8 months since injury 4. Lack of medical contraindications to engage in physical exercise of moderate or vigorous intensity 5. Preserved communication abilities to perform neuropsychological assessments, and to give informed consent

Exclusion criteria

Exclusion criteria: 1. Drug abuse or addiction

Design outcomes

Primary

Measure	Time frame
Cognitive function will be measured using the following set of neuropsychological tests: 1. Trail-making tests A and B 2. Rey-Osterrieth complex figure 3. Wisconsin card sorting test 4. Symbol digits modalities test 5. Letters and numbers 6. Forwards and backwards digit span The tests will be administered at four different time points: 1. At the beginning of the study (week 1; baseline) 2. Immediately before the exercise intervention (week 20) 3. Immediately after the exercise intervention (week 40) 4. At the end of the study (week 60; follow-up):	—

Measure

Time frame

Cognitive function will be measured using the following set of neuropsychological tests: 1. Trail-making tests A and B 2. Rey-Osterrieth complex figure 3. Wisconsin card sorting test 4. Symbol digits modalities test 5. Letters and numbers 6. Forwards and backwards digit span The tests will be administered at four different time points: 1. At the beginning of the study (week 1; baseline) 2. Immediately before the exercise intervention (week 20) 3. Immediately after the exercise intervention (week 40) 4. At the end of the study (week 60; follow-up):

—

Secondary

Measure	Time frame
1. Physical activity in daily life measured using an Actigraph at three time periods, in the middle of phase A1 (pre-intervention); in the middle of phase B (during the period of exercise intervention), and in the middle of phase A2 (follow-up), on weeks 9-10; 29-30 and 50-51 of the study. Each recording period has a duration of 7 consecutive days 2. Perceived quality of life measured using the CAVIDACE scale ("Quality of life for brain-injured patients") at the same four times as cognitive testing 3. Sympathetic/parasympathetic balance measured using heart rate variability at the beginning and end of the period of exercise intervention (weeks 20 and 40)	—

Measure

Time frame

1. Physical activity in daily life measured using an Actigraph at three time periods, in the middle of phase A1 (pre-intervention); in the middle of phase B (during the period of exercise intervention), and in the middle of phase A2 (follow-up), on weeks 9-10; 29-30 and 50-51 of the study. Each recording period has a duration of 7 consecutive days 2. Perceived quality of life measured using the CAVIDACE scale ("Quality of life for brain-injured patients") at the same four times as cognitive testing 3. Sympathetic/parasympathetic balance measured using heart rate variability at the beginning and end of the period of exercise intervention (weeks 20 and 40)

—

Countries

Spain

Contacts

Public ContactMargalida Coll Andreu

Margalida.Coll@uab.cat+34 935811173

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026