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

NCT03526653 | Completed

• 1 other identifier: PAIE-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Elderly

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• Glucose

  baseline

• Glucose

  minute 30

• Insulin

  baseline

• Insulin

  minute 30

• Heart rate

  baseline

Study Arms (4)

Intervention 1

OTHER

exercise on an ergometer or motomed in an environment without other visual stimuli

Other: exercise without visual stimuli

Intervention 2

OTHER

exercise on an ergometer or motomed while watching the National Geografics channel on television

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

Other: Exercise with MemoRide

Control group

NO INTERVENTION

Rest during 30 minutes

Interventions

exercise without visual stimuli OTHER

exercise on an ergometer or motomed in an environment without other visual stimuli

Intervention 1

excercise with National Geografics OTHER

exercise on an ergometer or motomed while watching the National Geografics channel on television

Intervention 2

Exercise with MemoRide OTHER

excercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner

Intervention 3

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

WZC Begralim (Campus Sint-Elisabeth)

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dominique Hansen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Nastasia Marinus, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 16, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

BE (1)