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

NCT ID: NCT03526653

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intervention 1

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

Group Type: OTHER

exercise without visual stimuli

Intervention Type: OTHER

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

Intervention 2

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

Group Type: OTHER

excercise with National Geografics

Intervention Type: OTHER

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

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

Group Type: OTHER

Exercise with MemoRide

Intervention Type: 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

Control group

Rest during 30 minutes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise without visual stimuli

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

Intervention Type: OTHER

excercise with National Geografics

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

Intervention Type: 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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dominique Hansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique Hansen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Nastasia Marinus, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

WZC Begralim (Campus Sint-Elisabeth)

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

PAIE-001

Identifier Type: -

Identifier Source: org_study_id