The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure

NCT04254328 | Completed

• 1 other identifier: 28/06/2019-908
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a multisystem syndrome characterized by the body's inability to pump or increase the filling pressures required for pumping the blood needed. Typically it shows objective evidence of dyspnea and fatigue during rest or exercise, or swelling of the ankles and cardiac dysfunction. This leads to great loss of functional status and quality of life. These patients seem to be more difficult to participate in cardiac rehabilitation programs due to their more comorbid, fragile and low functional capacity. It has been shown that inspiratory muscle training, which is a part of cardiac rehabilitation, not only improves lung problems but also increases functional capacity and balance, strength of respiratory and peripheral muscles, and decreases perception of depression and dyspnea in patients. Video games are increasingly being used as an alternative to traditional rehabilitation-based exercises to improve daily activity levels and increase physical fitness in the elderly because of their recreational and motivational effects. Although Nintendo wii fit gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for elderly people with low energy levels. A review showed that video games are safe and feasible in the elderly with heart failure. Participants' balance, cognitive functions, quality of life improved and depressive mood decreased. Video games also make older people to communicate better with other family members. The aim of this study was to investigate the effectiveness of inspiratory muscle training and nintendo wii fit exercise training in elderly patients with heart failure and to compare these practices with each other.

Conditions

Heart Failure; Older People

Keywords

heart failure; older; physical activity; inspiratory muscle training; nintendo

Outcome Measures

Primary Outcomes (3)

• The six-minute walk test (6MWT)

  6MWT is used to determine functional exercise capacity, assess treatment efficacy, predict prognosis. This test is applied in a certain length corridor with the start and end point during 6 minute-walk. Before the test, patient is seated in a chair and rest for 10 minutes. Resting blood pressure, pulse, oxygen saturation value, dyspnea and fatigue score is recorded before and immediate after test. Before starting to test, patient is warned to tell if any problem is seen such as dizziness, pain, cramp. The patient is then asked to walk at a fast pace with a supervisor for 6 minutes. If the patient has a significant problem such as dizziness, pain, palpitation , the test is terminated immediately. At the end of test, how many meters the patient has walked for 6 minutes has recorded.

  0-8 weeks

• The Timed Up and Go test (TUG)

  The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time it takes for a person to get out of the chair, walk three meters, turn around, return to the chair and sit down.

  0-8 weeks

• The Short Physical Performance Battery Test (SPPB)

  The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.

  0-8 weeks

Study Arms (3)

Nintendo Wii Fit

EXPERIMENTAL

Nintendo Wii Fit group work program; 13 exercises in 5 groups including 3 yoga exercises, 3 balance exercises, 2 aerobic, 2 training plus exercises and 3 muscle-workout will be done respectively. Patients in this group will exercise for 8 weeks, 3 days in a week and 40-50 minutes of exercise within resting interval.

Device: Nintendo Wii Fit

Respiratory

EXPERIMENTAL

Respiratory training group participants' will do deep breathing exercise against resistance of 30% of intraoral pressure. This exercise will be applied for 8 weeks, each day of the week, twice in a day for 15 minutes and 4-5 normal breaths after 4-5 deep breaths. Each week, intraoral pressure will be measured and new training intensity values will be determined.

Device: Threshold IMT

Control

NO INTERVENTION

Patients in the control group will not be included in any exercise program, but all groups will be advised of walking in order to increase physical activity level.

Interventions

Nintendo Wii Fit DEVICE

Nintendo Wii Fit group will perform including a series of yoga, balance, aerobics and muscle workout exercises by providing visual feedback on the TV screen with the Nintendo wii fit plus game console. Patients will perform these exercises in a room allocated to the thesis supervisor and together with the thesis supervisor physiotherapist. This process takes 40-50 minutes. Before starting test and after test, weight, blood pressure, pulse, respiratory rate, oxygen saturation value will be recorded. Patients will be rested if necessary during exercise.

Nintendo Wii Fit

Threshold IMT DEVICE

Patients in the breathing exercise group will perform deep breathing exercises at home by a small breathing apparatus called as Threshold IMT. It has no unexpected side effects.Patients will do this exercise twice in a day ; morning and evening during 15 minutes. After 4-5 deep breath, patients will take normal breath till feeling relaxed.

Respiratory

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• individual who can walk (even with the help of any device)
• an individual without visual and auditory impairment
• an individual who is cognitive to understand commands
• Stable individual with medical condition
• the individual signing the informed consent form

You may not qualify if:

• under 60 years
• the person who cannot walk (even with the help of any device)
• with visual or auditory impairment
• MI in the past 6 months
• previous ischemic attack
• severe cognitive impairment
• serious musculoskeletal disorders
• symptomatic medical conditions that prevent exercise (pulmonary, cardiovascular, cancer, psychiatric, etc.)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Kaminsky LA, Tuttle MS. Functional assessment of heart failure patients. Heart Fail Clin. 2015 Jan;11(1):29-36. doi: 10.1016/j.hfc.2014.08.002. Epub 2014 Sep 23.

  PMID: 25432472 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Rodriguez-Pascual C, Paredes-Galan E, Ferrero-Martinez AI, Gonzalez-Guerrero JL, Hornillos-Calvo M, Menendez-Colino R, Torres-Torres I, Vilches-Moraga A, Galan MC, Suarez-Garcia F, Olcoz-Chiva MT, Rodriguez-Artalejo F. The frailty syndrome is associated with adverse health outcomes in very old patients with stable heart failure: A prospective study in six Spanish hospitals. Int J Cardiol. 2017 Jun 1;236:296-303. doi: 10.1016/j.ijcard.2017.02.016. Epub 2017 Feb 8.

  PMID: 28215465 BACKGROUND

• Bosnak-Guclu M, Arikan H, Savci S, Inal-Ince D, Tulumen E, Aytemir K, Tokgozoglu L. Effects of inspiratory muscle training in patients with heart failure. Respir Med. 2011 Nov;105(11):1671-81. doi: 10.1016/j.rmed.2011.05.001. Epub 2011 May 31.

  PMID: 21621993 BACKGROUND

• Bonnechere B, Jansen B, Omelina L, Van Sint Jan S. The use of commercial video games in rehabilitation: a systematic review. Int J Rehabil Res. 2016 Dec;39(4):277-290. doi: 10.1097/MRR.0000000000000190.

  PMID: 27508968 BACKGROUND

• Griffin M, Shawis T, Impson R, Shanks J, Taylor MJ. Comparing the Energy Expenditure of Wii Fit()-Based Therapy Versus Traditional Physiotherapy. Games Health J. 2013 Aug;2(4):229-34. doi: 10.1089/g4h.2012.0078. Epub 2013 Jul 23.

  PMID: 26192226 BACKGROUND

• Verheijden Klompstra L, Jaarsma T, Stromberg A. Exergaming in older adults: a scoping review and implementation potential for patients with heart failure. Eur J Cardiovasc Nurs. 2014 Oct;13(5):388-98. doi: 10.1177/1474515113512203. Epub 2013 Nov 6.

  PMID: 24198306 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Rengin Demir, Prof Dr

  Istanbul University-Cerrahpasa Institute of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: February 5, 2020
• Study Start: September 5, 2019
• Primary Completion: March 11, 2020
• Study Completion: December 21, 2021
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)