Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
Primary Purpose
Physical Activity, Elderly
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
exercise without visual stimuli
excercise with National Geografics
Exercise with MemoRide
Sponsored by
About this trial
This is an interventional screening trial for Physical Activity
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)
Sites / Locations
- WZC Begralim (Campus Sint-Elisabeth)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
No Intervention
Arm Label
Intervention 1
Intervention 2
Intervention 3
Control group
Arm Description
exercise on an ergometer or motomed in an environment without other visual stimuli
exercise on an ergometer or motomed while watching the National Geografics channel on television
exercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner
Rest during 30 minutes
Outcomes
Primary Outcome Measures
Brain Derived Neurotrophic Factor (BDNF)
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
Brain Derived Neurotrophic Factor (BDNF)
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
evaluation of distance via data on the exercise bike
Velocity
evaluation of velocity via data on the exercise bike and pedalling sensor
Intrinsic Motivation Inventory
evaluation of motivation via Intrinsic Motivation Inventory questionaire
Observed Emotion Rating Scale
evaluation of emotions via an observation scale (Observed Emotion Rating Scale)
Fatigue
evaluation of perceived exertion via the BORG-scale
Credibility-Expectancy Questionnaire
evaluation of motivation via Credibility-Expectancy Questionnaire
Secondary Outcome Measures
Glucose
Evaluation of glucose via a blood sample
Glucose
Evaluation of glucose via a blood sample
Insulin
Evaluation of insulin via a blood sample
Insulin
Evaluation of insulin via a blood sample
Heart rate
Evaluation of heart rate via a heart rate monitor
Heart rate
Evaluation of heart rate via a heart rate monitor
systolic and diastolic blood pressure
Evaluation of blood pressure via a blood pressure monitor
systolic and diastolic blood pressure
Evaluation of blood pressure via a blood pressure monitor
Lactate
Evaluation of lactate via a finger prick
depressed feelings
Evaluation of depressed feelings via a questionnaire (Geriatric Depression Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03526653
Brief Title
Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
Official Title
Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Elderly
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1
Arm Type
Other
Arm Description
exercise on an ergometer or motomed in an environment without other visual stimuli
Arm Title
Intervention 2
Arm Type
Other
Arm Description
exercise on an ergometer or motomed while watching the National Geografics channel on television
Arm Title
Intervention 3
Arm Type
Other
Arm Description
exercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Rest during 30 minutes
Intervention Type
Other
Intervention Name(s)
exercise without visual stimuli
Intervention Description
exercise on an ergometer or motomed in an environment without other visual stimuli
Intervention Type
Other
Intervention Name(s)
excercise with National Geografics
Intervention Description
exercise on an ergometer or motomed while watching the National Geografics channel on television
Intervention Type
Other
Intervention Name(s)
Exercise with MemoRide
Intervention Description
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 Outcome Measure Information:
Title
Brain Derived Neurotrophic Factor (BDNF)
Description
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
Time Frame
Baseline
Title
Brain Derived Neurotrophic Factor (BDNF)
Description
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
Time Frame
minute 30
Title
Distance immediately post-intervention
Description
evaluation of distance via data on the exercise bike
Time Frame
minute 30
Title
Velocity
Description
evaluation of velocity via data on the exercise bike and pedalling sensor
Time Frame
minute 30
Title
Intrinsic Motivation Inventory
Description
evaluation of motivation via Intrinsic Motivation Inventory questionaire
Time Frame
minute 30
Title
Observed Emotion Rating Scale
Description
evaluation of emotions via an observation scale (Observed Emotion Rating Scale)
Time Frame
minute 30
Title
Fatigue
Description
evaluation of perceived exertion via the BORG-scale
Time Frame
minute 30
Title
Credibility-Expectancy Questionnaire
Description
evaluation of motivation via Credibility-Expectancy Questionnaire
Time Frame
minute 30
Secondary Outcome Measure Information:
Title
Glucose
Description
Evaluation of glucose via a blood sample
Time Frame
baseline
Title
Glucose
Description
Evaluation of glucose via a blood sample
Time Frame
minute 30
Title
Insulin
Description
Evaluation of insulin via a blood sample
Time Frame
baseline
Title
Insulin
Description
Evaluation of insulin via a blood sample
Time Frame
minute 30
Title
Heart rate
Description
Evaluation of heart rate via a heart rate monitor
Time Frame
baseline
Title
Heart rate
Description
Evaluation of heart rate via a heart rate monitor
Time Frame
minute 30
Title
systolic and diastolic blood pressure
Description
Evaluation of blood pressure via a blood pressure monitor
Time Frame
baseline
Title
systolic and diastolic blood pressure
Description
Evaluation of blood pressure via a blood pressure monitor
Time Frame
minute 30
Title
Lactate
Description
Evaluation of lactate via a finger prick
Time Frame
minute 30
Title
depressed feelings
Description
Evaluation of depressed feelings via a questionnaire (Geriatric Depression Scale)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nastasia Marinus, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
WZC Begralim (Campus Sint-Elisabeth)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
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Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
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