Physical ActivityNCT03526653

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

A study testing exercise without visual stimuli, excercise with National Geografics and Exercise with MemoRide in people with Physical Activity and Elderly, run by Hasselt University at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for: Physical Activity, Elderly
What is being tested?: exercise without visual stimuli, excercise with National Geografics and Exercise with MemoRide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteBelgium
Study dates: 1 Apr 2018to 1 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

WZC Begralim (Campus Sint-Elisabeth)
Hasselt, 3500

Other trials in Belgium

About this study

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.

Conditions: Physical Activity, Elderly
Being tested: exercise without visual stimuli, excercise with National Geografics, Exercise with MemoRide
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exercise without visual stimuliOther
exercise on an ergometer or motomed in an environment without other visual stimuli
excercise with National GeograficsOther
exercise on an ergometer or motomed while watching the National Geografics channel on television
Exercise with MemoRideOther
excercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner

Study groups in NCT03526653
Study group	Role	What they receive
Intervention 1	Other	exercise on an ergometer or motomed in an environment without other visual stimuli Receives: Other: exercise without visual stimuli
Intervention 2	Other	exercise on an ergometer or motomed while watching the National Geografics channel on television Receives: Other: excercise with National Geografics
Intervention 3	Other	exercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner Receives: Other: Exercise with MemoRide
Control group	No intervention	Rest during 30 minutes

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline
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
Measured: minute 30
Distance immediately post-intervention
evaluation of distance via data on the exercise bike
Measured: minute 30
Velocity
evaluation of velocity via data on the exercise bike and pedalling sensor
Measured: minute 30
Intrinsic Motivation Inventory
evaluation of motivation via Intrinsic Motivation Inventory questionaire
Measured: minute 30
Observed Emotion Rating Scale
evaluation of emotions via an observation scale (Observed Emotion Rating Scale)
Measured: minute 30
Fatigue
evaluation of perceived exertion via the BORG-scale
Measured: minute 30
Credibility-Expectancy Questionnaire
evaluation of motivation via Credibility-Expectancy Questionnaire
Measured: minute 30

Secondary outcomes (10)

Glucose
Evaluation of glucose via a blood sample
Measured: baseline
Glucose
Evaluation of glucose via a blood sample
Measured: minute 30
Insulin
Evaluation of insulin via a blood sample
Measured: baseline
Insulin
Evaluation of insulin via a blood sample
Measured: minute 30
Heart rate
Evaluation of heart rate via a heart rate monitor
Measured: baseline
Heart rate
Evaluation of heart rate via a heart rate monitor
Measured: minute 30
systolic and diastolic blood pressure
Evaluation of blood pressure via a blood pressure monitor
Measured: baseline
systolic and diastolic blood pressure
Evaluation of blood pressure via a blood pressure monitor
Measured: minute 30
Lactate
Evaluation of lactate via a finger prick
Measured: minute 30
depressed feelings
Evaluation of depressed feelings via a questionnaire (Geriatric Depression Scale)
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20181 Jun 2018

First posted16 May 2018
Study start1 Apr 2018
Primary completion1 Jun 2018
Study completion1 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03526653
Sponsor's protocol ID: PAIE-001
Status last verified: Nov 2019
First submitted: 21 Apr 2018
Last updated: 21 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pauwels S, Lemkens N, Lemmens W, Meijer K, Meyns P, Berg RVD, Spildooren J. The Importance of Frailty in Older Adults With Benign Paroxysmal Positioning Vertigo. J Neurol Phys Ther. 2025 Apr 1;49(2):99-107. doi: 10.1097/NPT.0000000000000495. Epub 2024 Nov 22.
PubMed 39805124

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency

All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?
ClinicalTrials.gov ID: NCT03526653
Acronym / sponsor ID: PAIE-001
Conditions: Physical Activity, Elderly
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Hasselt UniversityUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 16 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Intervention 1	Other	Other: exercise without visual stimuliexercise on an ergometer or motomed in an environment without other visual stimuli
Intervention 2	Other	Other: excercise with National Geograficsexercise on an ergometer or motomed while watching the National Geografics channel on television
Intervention 3	Other	Other: Exercise with MemoRideexercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner
Control group	No intervention	–Rest during 30 minutes

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exercise without visual stimuliexercise on an ergometer or motomed in an environment without other visual stimuli	Other	Intervention 1
excercise with National Geograficsexercise on an ergometer or motomed while watching the National Geografics channel on television	Other	Intervention 2
Exercise with MemoRideexcercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner	Other	Intervention 3

Primary outcome

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
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
Velocity
Time frame: minute 30
evaluation of velocity via data on the exercise bike and pedalling sensor
Intrinsic Motivation Inventory
Time frame: minute 30
evaluation of motivation via Intrinsic Motivation Inventory questionaire
Observed Emotion Rating Scale
Time frame: minute 30
evaluation of emotions via an observation scale (Observed Emotion Rating Scale)
Fatigue
Time frame: minute 30
evaluation of perceived exertion via the BORG-scale
Credibility-Expectancy Questionnaire
Time frame: minute 30
evaluation of motivation via Credibility-Expectancy Questionnaire

10 secondary outcomes

Glucose
Time frame: baseline
Glucose
Time frame: minute 30
Insulin
Time frame: baseline
Insulin
Time frame: minute 30
Heart rate
Time frame: baseline
Heart rate
Time frame: minute 30
systolic and diastolic blood pressure
Time frame: baseline
systolic and diastolic blood pressure
Time frame: minute 30
Lactate
Time frame: minute 30
depressed feelings
Time frame: baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
Derived from this study: PubMed 39805124Pauwels S, Lemkens N, Lemmens W, Meijer K, Meyns P, Berg RVD, Spildooren J. The Importance of Frailty in Older Adults With Benign Paroxysmal Positioning Vertigo. J Neurol Phys Ther. 2025 Apr 1;49(2):99-107. doi: 10.1097/NPT.0000000000000495. Epub 2024 Nov 22.

Related trials for Physical Activity

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dominique Hansen, prof. dr. principal investigator

Hasselt University

Nastasia Marinus, drs. study chair

Hasselt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Derived Neurotrophic Factor (BDNF) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526653, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.