Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain

NCT ID: NCT05585294

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-21

Study Completion Date

2022-11-30

Brief Summary

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The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Overweight/obese subgroup was compared with healthy weight with chronic low back pain participants to investigate any effect on BMI on both interventions. The results of the study revealed that both exercise groups i.e., land and water based exercise had a significant reduction in pain level, fear of falling, fear avoidance belief related to work, disability and improved SLR.

Detailed Description

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Twenty-four grouped into 12 per group participated water based and land based exercise protocol. Both groups were given McKenzie Method of exercises in 1st week based on the treatment-based classification (TBC) approach or personalized to the need of participants as per TBC.

Perturbation-based postural exercises were given to participants, which were performed on land or water for 6 weeks.

The perturbation based exercises were categorized into four levels, where level 1:static postural control, 2:dynamic postural control 3:Extremity loaded postural control and 4: cognitive task associated postural control. The perturbation were provided at shoulder and hip level, by intervention providers progressive enough to initiate anticipatory or compensatory postural adjustments.

Both groups were educated on pain assurance and spinal ergonomics feedback. The Outcomes were measured using a Visual analog scale, Oswestry disability index, Fear avoidance belief questionnaire, Straight leg raise, Modified fall efficacy scale, and Borg scale. The pain level were assessed for personalized progression from level 1 to level 4 progression of perturbation exercises.

Both the exercise groups of land and water showed improvement in measured clinical outcomes in terms of reduction in pain level, fear of falling, fear avoidance belief related to work, SLR, and disability. Water-based group showed additional benefits and significant improvement in fear avoidance belief related to physical activity and exercised with low rate of perceived exertion.

Conditions

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Back Pain Back Pain With Radiation Back Pain Without Radiation Back Pain Lower Back Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

pre and post outcomes comparison after clinical intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Outcome assessor unaware of what care was provided, and care was provided by other providers. Possibility of sequential trail is considered. The value of p will be adjusted depending the number of analysis made and stopping rule will be followed.

Study Groups

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Water based perturbation exercise group

In both groups, the participants screened for Treatment-based classification of back pain and based on TBC interventions were provided. From second week, water based perturbation exercise were initiated personalized to the level of participants.

Treatment-based classification of back pain intervention was gradually tapered in orderly fashion during 6 weeks, concurrently introduced land based perturbation exercise gradually phased from level 1 to level 4.

Group Type EXPERIMENTAL

Exercises

Intervention Type BEHAVIORAL

Perturbation exercises: A new protocol of perturbation exercises aimed to disturb static and dynamic posture or equilibrium at primarily at body segments at hip and shoulder level were provided. The perturbation was initially started as anticipatory postural adjustment and progressed to compensatory postural adjustment, where stepping on various directions were challenged. The nature of perturbation or push or nudges applied by physiotherapists were progressed from a) self-generated to therapist applied, anticipated to unanticipated, stable to unstable platforms, static to dynamic postural tasks with loaded extremities and at higher level simple to higher cognitive tasks were also incorporated.

Land based perturbation exercise group

All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land.

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type BEHAVIORAL

Perturbation exercises: A new protocol of perturbation exercises aimed to disturb static and dynamic posture or equilibrium at primarily at body segments at hip and shoulder level were provided. The perturbation was initially started as anticipatory postural adjustment and progressed to compensatory postural adjustment, where stepping on various directions were challenged. The nature of perturbation or push or nudges applied by physiotherapists were progressed from a) self-generated to therapist applied, anticipated to unanticipated, stable to unstable platforms, static to dynamic postural tasks with loaded extremities and at higher level simple to higher cognitive tasks were also incorporated.

Interventions

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Exercises

Perturbation exercises: A new protocol of perturbation exercises aimed to disturb static and dynamic posture or equilibrium at primarily at body segments at hip and shoulder level were provided. The perturbation was initially started as anticipatory postural adjustment and progressed to compensatory postural adjustment, where stepping on various directions were challenged. The nature of perturbation or push or nudges applied by physiotherapists were progressed from a) self-generated to therapist applied, anticipated to unanticipated, stable to unstable platforms, static to dynamic postural tasks with loaded extremities and at higher level simple to higher cognitive tasks were also incorporated.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC system

Eligibility Criteria

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Inclusion Criteria

* Pain history of minimum 12 weeks duration in below labels
* Participants with the diagnostic labels of spondylosis
* Non-specific chronic low back pain
* Back pain radiating to leg or sciatica
* Subacute back pain

Exclusion Criteria

* Unstable blood pressure
* Cardiac failure
* Incontinence
* Uncontrolled epilepsy
* Open wounds
* Acute infections
* Neurological disorders
* Orthopedic conditions affecting exercise participation in pool and land
* Cardio-respiratory conditions affecting exercise participation in pool and land.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Srinivas University

UNKNOWN

Sponsor Role collaborator

Gulf Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rania Zaarour

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Ramprasad Muthukrishnan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gulf Medical Univesity

Locations

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Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital

Ajman, , United Arab Emirates

Site Status

Gulf Medical University

Ajman, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

References

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Muthukrishan R, Badr Ul Islam FM, Shanmugam S, Arulsingh W, Gopal K, Kandakurti PK, Rajasekar S, Malik GS, S G G. Perturbation-based Balance Training in Adults Aged Above 55 Years with Chronic Low Back Pain: A Comparison of Effects of Water versus Land Medium - A Preliminary Randomized Trial. Curr Aging Sci. 2024;17(2):156-168. doi: 10.2174/0118746098254991231125143735.

Reference Type DERIVED
PMID: 38111118 (View on PubMed)

Other Identifiers

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COHS_UG_Research_6122017

Identifier Type: OTHER

Identifier Source: secondary_id

INT/COHS/UG/012-2019

Identifier Type: -

Identifier Source: org_study_id

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