Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial (SMART)

Professor Johannes Pantel

Status: Completed

Conditions: Cognitive Impairment; Dementia

Treatments: Other: Waiting Control; Other: Individualised aerobic exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02343029

SMART

Details and patient eligibility

About

Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. be above 65 years of age,
2. voluntariness
3. capacity to consent,
4. having passed medical entry exam by the Department of Sports Medicine,

4. regular mental capacity, 5) written informed consent

Exclusion criteria

1. untreated clotting disorders,
2. musculoskeletal diseases significantly reducing mobility,
3. severe bacterial or viral infections,
4. severe respiratory diseases (Gold IV),
5. acute pulmonary embolism,
6. instable angina pectoris or severe heart failure (NYHA III or IV),
7. severe vascular disease of the extremities or the brain,
8. severe pulmonary-cardiac dysfunction,
9. acute myocardial infarction or early phase of rehabilitation,
10. critical aortal stenosis,
11. severe hypertrophic and obstructive cardiomyopathy,
12. untreated malignant arrhythmias,
13. untreated severe hypertonia,
14. severe pulmonary hypertonia,
15. symptomatic cardiac malformations,
16. cardiac-block grade II or III,
17. left bundle branch block,
18. complex ventricular arrhythmias,
19. Cognitive impairment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants in the Intervention group exercise three times a week for 30 minutes on a bicycle ergometer (optibike med, ergoline GmbH, Bitz, Germany) in the integrated gym hall of one of the participating residencies. Training is individualised as respective performance is adapted to the power at the first ventilator threshold (assessed during cardiopulmonary exercise test).

Treatment:

Other: Individualised aerobic exercise training

Waiting Control

Active Comparator group

Description:

Participants of Waiting Control continue their regular physical activity behaviour for 12 weeks. They will start the same exercise intervention after a reassessment at week 12 for the next upcoming 12 weeks. (13-24)

Treatment:

Other: Waiting Control

Other: Individualised aerobic exercise training