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A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma

A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma - Effects of exercise on cognitive function in glioma patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40500
Enrollment
170
Registered
2013-06-27
Start date
2013-08-13
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cognitieve stoornissen glioma

Interventions

Patients in the intervention group will undergo a 6-month home-based exercise intervention. An individual exercise prescription will be based on the patients* level of aerobic fitness (VO2peak) as m

Sponsors

Universiteit van Tilburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with supratentorial glioma, in particular: (1a) histologically proven low-grade glioma (LGG; astrocytoma, oligodendroglioma, oliogo-astrocytoma), or presumed (i.e., suspected) LGG based on both clinical and MR imaging features (>18 years of age 70), who: (2) have been clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MR imaging); and (3) have had no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); and (4) are interested in undergoing a physical exercise program; and (5) have a relative VO2peak (% predicted based on variables such as age and gender) that leaves room for further improvement of cardiorespiratory fitness.

Exclusion criteria

Exclusion criteria: Potentially eligible patients will be screened for the presence of comorbid conditions that would contraindicate participation in a physical activity/exercise program. This includes patients with serious orthopedic conditions or motor deficits, and patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients judged to have psychiatric (including alcohol and drug abuse) or severe cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language. In addition, patients who report to engage in vigorous exercise (>=7 METs (Metabolic equivalents of task)) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded from participation, as there will be no room for further improvement of aerobic fitness.

Design outcomes

Primary

MeasureTime frame
Primary outcome measures will include indicators of feasibility (accrual, adherence, compliance and attrition) and (size of the effect on) performance scores on neuropsychological testing (attention, memory and executive function).

Secondary

MeasureTime frame
Secondary outcome measures will include performance measures of physical fitness as measured with CPET (cardiorespiratory exercise testing on a cycle ergometer with ECG and gas exchange measurement), and self-report questionnaires of subjective cognitive functioning, fatigue, sleep, mood and quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)