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

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ClinicalTrials.gov Identifier: NCT03526653
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University

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.


Condition or disease Intervention/treatment Phase
Physical Activity Elderly Other: exercise without visual stimuli Other: excercise with National Geografics Other: Exercise with MemoRide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention 1
exercise on an ergometer or motomed in an environment without other visual stimuli
Other: exercise without visual stimuli
exercise on an ergometer or motomed in an environment without other visual stimuli

Intervention 2
exercise on an ergometer or motomed while watching the National Geografics channel on television
Other: excercise with National Geografics
exercise on an ergometer or motomed while watching the National Geografics channel on television

Intervention 3
exercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner
Other: Exercise with MemoRide
excercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner

No Intervention: Control group
Rest during 30 minutes



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526653


Contacts
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Contact: Dominique Hansen, prof. dr. +32 11 26 21 26 dominique.hansen@uhasselt.be
Contact: Nastasia Marinus, drs. +32 11 26 93 05 nastasia.marinus@uhasselt.be

Locations
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Belgium
WZC Begralim (Campus Sint-Elisabeth) Recruiting
Hasselt, Belgium, 3500
Contact: Nastasia Marinus, drs.    +32 11 26 93 05    nastasia.marinus@uhasselt.be   
Contact: Bart Vossen    +32 498 32 58 63    bbohasselt@begralim.be   
Principal Investigator: Dominique Hansen, prof. dr.         
Sub-Investigator: Nastasia Marinus, drs.         
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Dominique Hansen, prof. dr. Hasselt University
Study Chair: Nastasia Marinus, drs. Hasselt University

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Responsible Party: Dominique Hansen, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03526653     History of Changes
Other Study ID Numbers: PAIE-001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes