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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Elderly
• Intervention / Treatment: Other: exercise without visual stimuli; Other: excercise with National Geografics; Other: Exercise with MemoRide

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • WZC Begralim (Campus Sint-Elisabeth)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Study Chair: Nastasia Marinus, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PAIE-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No