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Completed

NCT Number: NCT03526653

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WZC Begralim (Campus Sint-Elisabeth)

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exercise without visual stimuli

Other

exercise on an ergometer or motomed in an environment without other visual stimuli

excercise with National Geografics

Other

exercise on an ergometer or motomed while watching the National Geografics channel on television

Exercise with MemoRide

Other

excercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner

Primary outcomes

  1. Brain Derived Neurotrophic Factor (BDNF)

    Time frame: Baseline

    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

  2. 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

  3. Distance immediately post-intervention

    Time frame: minute 30

    evaluation of distance via data on the exercise bike

  4. Velocity

    Time frame: minute 30

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

  5. Intrinsic Motivation Inventory

    Time frame: minute 30

    evaluation of motivation via Intrinsic Motivation Inventory questionaire

  6. Observed Emotion Rating Scale

    Time frame: minute 30

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

  7. Fatigue

    Time frame: minute 30

    evaluation of perceived exertion via the BORG-scale

  8. Credibility-Expectancy Questionnaire

    Time frame: minute 30

    evaluation of motivation via Credibility-Expectancy Questionnaire

Secondary outcomes

  1. Glucose

    Time frame: baseline

    Evaluation of glucose via a blood sample

  2. Glucose

    Time frame: minute 30

    Evaluation of glucose via a blood sample

  3. Insulin

    Time frame: baseline

    Evaluation of insulin via a blood sample

  4. Insulin

    Time frame: minute 30

    Evaluation of insulin via a blood sample

  5. Heart rate

    Time frame: baseline

    Evaluation of heart rate via a heart rate monitor

  6. Heart rate

    Time frame: minute 30

    Evaluation of heart rate via a heart rate monitor

  7. systolic and diastolic blood pressure

    Time frame: baseline

    Evaluation of blood pressure via a blood pressure monitor

  8. systolic and diastolic blood pressure

    Time frame: minute 30

    Evaluation of blood pressure via a blood pressure monitor

  9. Lactate

    Time frame: minute 30

    Evaluation of lactate via a finger prick

  10. depressed feelings

    Time frame: baseline

    Evaluation of depressed feelings via a questionnaire (Geriatric Depression Scale)

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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