IRCT | Comparison of the Acute Effects of XBOX 360 Kinect Exergames and Core Stability Exercises on Cognition Factors, Pain, Mood, Fatigue and Fear Avoidance Beliefs in People with Chronic Non-Specific Low Back Pain.

Protocol summary

Study aim: The present study aims to determine whether exergames can immediately enhance cognitive factors, perceived level of exertion due to exercising, mood states, and improvement of fear-avoidance beliefs and pain in subjects with CLBP. The treatment effectiveness of exergames will then be compared to regular core stability exercises.
Design: Randomized single-blinded clinical trial, with two interventional groups (exergames and core stability exercises), on 48 subjects with CLBP
Settings and conduct: Forty-eight subjects with non-specific CLBP based on inclusion/exclusion criteria participate. Participants are randomized into 2 interventional groups: XBOX 360 Kinect exergames or core stability exercises. Subjects in each group are blinded to the intervention of another group. Pre/post assessments and interventions take place in a single session. Cognitive factors (working memory and attention), pain, fear avoidance beliefs and mood will be assessed. Acute pre- to post-changes will be compared within each group and between both groups. In addition, the perceived level of exertion after exercise is assessed and compared between two groups.
Participants/Inclusion and exclusion criteria: All men and women aged between 25 and 40, who have a history of LBP for at least 3 months, cognitive impairments, 7>VAS≥3 during assessment and intervention and using no painkiller during previous 48h; include. Anyone with a history of spinal and underlying disease, pregnancy, BMI≥25 Kg/m2, visual-auditory and balance disturbance, disability in learning and performing the interventional program and previous experience of using Xbox Kinect; exclude.
Intervention groups: In the exergaming group, subjects play with XBOX 360 Kinect games. In the other group, subjects perform core stability exercises.
Main outcome variables: Working memory, Attention, Level of pain, Fear avoidance beliefs

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20090203001637N12

Registration date: 2021-11-01, 1400/08/10

Registration timing: prospective

Last update: 2021-11-01, 1400/08/10

Update count: 0
Registration date: 2021-11-01, 1400/08/10

Registrant information: Name

Sedighe Kahrizi

Name of organization / entity

Tarbiat Modares University

Country

Iran (Islamic Republic of)

Phone

+98 21 8288 4511

Email address

kahrizis@modares.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-11-06, 1400/08/15
Expected recruitment end date: 2022-03-11, 1400/12/20
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the Acute Effects of XBOX 360 Kinect Exergames and Core Stability Exercises on Cognition Factors, Pain, Mood, Fatigue and Fear Avoidance Beliefs in People with Chronic Non-Specific Low Back Pain.

Public title: Acute effects of exergames on cognition in people with chronic non-specific low back pain
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

History of LBP for at least 3 months 7 > VAS ≥ 3 during assessment and intervention Not taking any painkillers 48 hours before the assessment and intervention Having cognitive impairments based on the scores of cognitive tests in matched healthy people Men and women between 25 and 40 years old

Exclusion criteria:

History of any spinal disease or related surgery History of cardiopulmonary disease, rheumatoid disease, and malignancy 3 > VAS ≥ 7 during the assessment and intervention BMI ≥ 25 Kg/m2 Pregnancy Visual or auditory disturbance Balance or vestibular impairments Disability in learning and performing the interventional program Previous experience of using Xbox 360 Kinect
Age: From 25 years old to 40 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 24

Randomization (investigator's opinion)

Randomized

Randomization description

According to the total sample size, a 48-digit random sequence is created using Online Randomization. The sequence of random numbers is then placed in opaque sealed envelopes, respectively. In order of arrival, subjects based on their envelope's number are randomly assigned to intervention one or intervention two groups.

Blinding (investigator's opinion)

Single blinded

Blinding description

Participants are not aware of the allocation of study groups .Thus subjects of the two groups do not meet and assessments take place separately in even and odd days.

Placebo

Not used

Assignment

Parallel

Other design features

In both groups, pre-assessments, interventions and post-assessments take place in a single session.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Tarbiat Modares University (T.M.U)

Street address

Medical Ethics Committee, Faculty of Medical Sciences,Tarbiat Modares University, Jalal Al Ahmad Highway

City

Tehran

Province

Tehran

Postal code

1411713116
Approval date: 2021-10-23, 1400/08/01
Ethics committee reference number: IR.MODAREC.REC.1400.199

Health conditions studied

1

Description of health condition studied: Chronic non-specific low back pain
ICD-10 code: M54.5
ICD-10 code description: Low back pain

Primary outcomes

1

Description: Working memory
Timepoint: Pre and post intervention
Method of measurement: N-Back software

2

Description: Attention
Timepoint: Pre and post intervention
Method of measurement: Simple Stroop test software

Secondary outcomes

1

Description: Level of pain
Timepoint: Pre and post intervention
Method of measurement: Visual analog scale (VAS)

2

Description: Fear avoidance beliefs
Timepoint: Pre and post intervention
Method of measurement: Tampa Scale of Kinesiophobia (TSK)

3

Description: Mood
Timepoint: Pre and post intervention
Method of measurement: The Brunel Mood Scale (BRUMS-32)

4

Description: Perceived level of exertion due to exercising
Timepoint: Post intervention
Method of measurement: BORG Rating of Perceived Exertion (RPE)

Intervention groups

1

Description: Exergaming group: A single exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) with Microsoft Xbox 360 Kinect games, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down.
Category: Rehabilitation

2

Description: Core stability exercising group: A single core stability exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) such as abdominal hollowing, bridges, plank holding, cat-camel, knee to chest, and quadruped core exercises, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Street address

Tarbiat Modares University, Jalal e ale ahmad Avenue, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 4511

Fax

+98 21 8288 4555

Email

Kahrizis@modares.ac.ir

Web page address

https://www.modares.ac.ir/~kahrizis

1

Sponsor: Name of organization / entity

Research Deputy of Tarbiat Modares University

Full name of responsible person

Dr.Yaghoub Fathollahi

Street address

Tarbiat Modares University, Jalal e ale ahmad Avenue, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 9002

Email

Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Research Deputy of Tarbiat Modares University
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Naghme Massah

Position

Student of M.sc in Physical Therapy

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8609 3437

Email

n.massah@modares.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 4511

Email

Kahrizis@modares.ac.ir

Web page address

https://www.modares.ac.ir/~kahrizis

Person responsible for updating data

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 4511

Email

kahrizis@modares.ac.ir

Web page address

https://www.modares.ac.ir/~kahrizis

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article
When the data will become available and for how long: Starting 6 months after publication of results
To whom data/document is available: The research team of this study and other clinical academic researchers who are studying in favor of these patients.
Under which criteria data/document could be used: Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document.
From where data/document is obtainable: Sedighe Kahrizi ; Naghme Massah, Randy Neblett
What processes are involved for a request to access data/document: The request will be responded after getting the approval of university or the academic institution
Comments

Comparison of the Acute Effects of XBOX 360 Kinect Exergames and Core Stability Exercises on Cognition Factors, Pain, Mood, Fatigue and Fear Avoidance Beliefs in People with Chronic Non-Specific Low Back Pain.