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Clinical Trials/NCT03526653
NCT03526653
Completed
Not Applicable

Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?

Hasselt University1 site in 1 country10 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
Hasselt University
Enrollment
10
Locations
1
Primary Endpoint
Brain Derived Neurotrophic Factor (BDNF)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Elderly in residential care spend 97% of their time sedentary. Moreover, exercise therapy often takes place in a poorly stimulating environment which is less motivational for the elderly to undertake regularly. Exercise is however necessary to preserve their physical capabilities and to limit their care dependence.

The aim of this study is to investigate the most motivating and stimulating exercise modality for prefrail and frail elderly in nursing homes with which they can reach sufficient training volume.

To study this, elderly will exercise in 3 different ways on an ergometer or motomed (according to their physical capabilities): 1) in an environment without other visual stimuli 2) in front of a television with National Geographic images 3) with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner.

MemoRide (Activ84Health) uses Google Street View images. The starting point is a connection between an exercise bike and a tablet with a pedalling sensor. This way, pedal frequency is sent to the tablet and as a result, images continue when pedalling.

The forth modality is the control modality, in which participants are instructed to rest (supine) during 30 minutes.

Based on objective training parameters and metabolic parameters e.g. glucose, insulin, brain-derived neurotrophic factor (BDNF) and lactate, (via a blood sample with a venous catheter) the training modality which offers the best training results will be studied. Secondly, also subject experiences (motivation and emotions) will be evaluated by using questionnaires and observation scales.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
June 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Dominique Hansen

Principal Investigator

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • Men and women with an age of at least 70 years at the start of the study;
  • Staying for at least one month in WZC St. Elisabeth Hasselt at the start of the study;
  • Being frail or prefrail (according to the criteria of Fried);
  • Being available to participate in the study during 4 consecutive weeks;
  • Being able to actively exercise on an exercise bike (if necessary from a wheelchair) during at least 5 minutes;
  • Understand simple instructions.

Exclusion Criteria

  • Any neurological or orthopedic disease which makes it impossible to exercise by bike actively e.g. stroke with hemiparesis of the lower limbs, amputations of the lower limbs,...;
  • Any disease which makes it impossible to exercise actively e.g. heart failure;
  • Any neurological or orthopedic disease from which progression (e.g. hip prosthesis, acute stroke) due to active recovery or decline (e.g. ALS (amyotropic lateral sclerosis), MS) due to the disease process can be expected on short term (1-2 months);
  • Being blind or visually impaired;
  • Any acute disease on the moment of the intervention which makes it impossible to exercise by bike during 30 minutes (e.g. hyper- or hypoglycemia) (reported by the caregiver)

Outcomes

Primary Outcomes

Brain Derived Neurotrophic Factor (BDNF)

Time Frame: minute 30

a protein produced inside the brain which can be transported outside the brain - it probably has a protective effect on neuronal survival and maintenance during adulthood

Distance immediately post-intervention

Time Frame: minute 30

evaluation of distance via data on the exercise bike

Fatigue

Time Frame: minute 30

evaluation of perceived exertion via the BORG-scale

Velocity

Time Frame: minute 30

evaluation of velocity via data on the exercise bike and pedalling sensor

Credibility-Expectancy Questionnaire

Time Frame: minute 30

evaluation of motivation via Credibility-Expectancy Questionnaire

Observed Emotion Rating Scale

Time Frame: minute 30

evaluation of emotions via an observation scale (Observed Emotion Rating Scale)

Intrinsic Motivation Inventory

Time Frame: minute 30

evaluation of motivation via Intrinsic Motivation Inventory questionaire

Secondary Outcomes

  • Glucose(minute 30)
  • Insulin(minute 30)
  • depressed feelings(baseline)
  • Heart rate(minute 30)
  • systolic and diastolic blood pressure(minute 30)
  • Lactate(minute 30)

Study Sites (1)

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