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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526653
• Other study ID #: PAIE-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Elderly
• Frailty
• Physical Activity

Intervention

Other:
• exercise without visual stimuli
exercise on an ergometer or motomed in an environment without other visual stimuli
• excercise with National Geografics
exercise on an ergometer or motomed while watching the National Geografics channel on television
• 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

Locations

Country	Name	City	State
Belgium	WZC Begralim (Campus Sint-Elisabeth)	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Distance immediately post-intervention	evaluation of distance via data on the exercise bike	minute 30
Primary	Velocity	evaluation of velocity via data on the exercise bike and pedalling sensor	minute 30
Primary	Intrinsic Motivation Inventory	evaluation of motivation via Intrinsic Motivation Inventory questionaire	minute 30
Primary	Observed Emotion Rating Scale	evaluation of emotions via an observation scale (Observed Emotion Rating Scale)	minute 30
Primary	Fatigue	evaluation of perceived exertion via the BORG-scale	minute 30
Primary	Credibility-Expectancy Questionnaire	evaluation of motivation via Credibility-Expectancy Questionnaire	minute 30
Secondary	Glucose	Evaluation of glucose via a blood sample	baseline
Secondary	Glucose	Evaluation of glucose via a blood sample	minute 30
Secondary	Insulin	Evaluation of insulin via a blood sample	baseline
Secondary	Insulin	Evaluation of insulin via a blood sample	minute 30
Secondary	Heart rate	Evaluation of heart rate via a heart rate monitor	baseline
Secondary	Heart rate	Evaluation of heart rate via a heart rate monitor	minute 30
Secondary	systolic and diastolic blood pressure	Evaluation of blood pressure via a blood pressure monitor	baseline
Secondary	systolic and diastolic blood pressure	Evaluation of blood pressure via a blood pressure monitor	minute 30
Secondary	Lactate	Evaluation of lactate via a finger prick	minute 30
Secondary	depressed feelings	Evaluation of depressed feelings via a questionnaire (Geriatric Depression Scale)	baseline