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

NCT05585294 | Completed DMC

• 2 other identifiers: INT/COHS/UG/012-2019COHS_UG_Research_6122017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Back Pain; Old Age; Exercises; Hydrotherapy; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Low back pain

  Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.

  6 weeks

• Disability caused by the chronic low back pain

  A standard Oswestry Disability Index (ODI) was used to evaluate the disability caused by the chronic low back pain. The lower the score lower disability and higher scores indicates that high level of disability associated with back pain.

  6 weeks

• Physical activity associated fear avoidance behavior

  The percentage of fear avoidance of behavior ranges from 0 to 100% where 0%-indicates no fear and 100%-indicate highest level of fear avoidance behavior.

  6 weeks

• Fall risk

  Fall risk of participants was assessed using the Modified fall efficacy scale (MFES), where Higher scores reflect more confidence and less fear of falling while lower scores reflect less confidence and more fear of falling.

  6 weeks

Secondary Outcomes (2)

• Rate of perceived exertion

  6 weeks

• Impairment - Straight Leg Raise as hip joint range of motion

  6 weeks

Study Arms (2)

Water based perturbation exercise group

EXPERIMENTAL

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.

Behavioral: Exercises

Land based perturbation exercise group

ACTIVE COMPARATOR

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

Behavioral: Exercises

Interventions

Exercises 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.

Also known as: Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC system

Land based perturbation exercise group; Water based perturbation exercise group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulf Medical University: lead
• Srinivas University: collaborator

Study Sites (2)

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

Ajman, United Arab Emirates

Location

Gulf Medical University

Ajman, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 38111118 DERIVED

MeSH Terms

Conditions

Back Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Ramprasad Muthukrishnan, Ph.D

  Gulf Medical Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: pre and post outcomes comparison after clinical intervention

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: December 21, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data is available and processed final.
• Access Criteria: Upon receipt of a request from other parties, for scientific purposes such as Systematic review and meta-analysis, the data will be shared, without disclosing the personal data.

Locations

AE (2)