Clinical trial NCT03526653: 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
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Elderly
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


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)

Primary outcomes:
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: minute 30
measure: Distance immediately post-intervention
timeFrame: minute 30
measure: Velocity
timeFrame: minute 30
measure: Intrinsic Motivation Inventory
timeFrame: minute 30
measure: Observed Emotion Rating Scale
timeFrame: minute 30
measure: Fatigue
timeFrame: minute 30
measure: Credibility-Expectancy Questionnaire
timeFrame: minute 30
Secondary outcomes:
measure: Glucose
timeFrame: baseline
measure: Glucose
timeFrame: minute 30
measure: Insulin
timeFrame: baseline
measure: Insulin
timeFrame: minute 30
measure: Heart rate
timeFrame: baseline
measure: Heart rate
timeFrame: minute 30
measure: systolic and diastolic blood pressure
timeFrame: baseline
measure: systolic and diastolic blood pressure
timeFrame: minute 30
measure: Lactate
timeFrame: minute 30
measure: depressed feelings
timeFrame: baseline
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: WZC Begralim (Campus Sint-Elisabeth)
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Nastasia Marinus, drs.
role: STUDY_CHAIR
References: