NCT04546646

Brief Summary

Locomotive syndrome is described as a condition in which mobility functions such as gait or Sit-to-stand are decreased due to impairment of the locomotive organs. Progression of locomotion syndrome causes limitation in carrying out activities of daily living (ADL) independently. So interventions are required to limit the progression of the syndrome and to sustain the functions of locomotive organs. This study will be a randomized controlled trial in which elastic band exercises are used to enhance the physical performance of community-dwelling elderly with locomotive syndrome and changes will be recorded using different methods and tools. Non-probability convenient sampling technique will be used to collect the data. The sample size of 24 patients will be taken in this study. Patients will be randomly allocated into two different groups through sealed envelope method. Group A will be treated with elastic band exercises and Group B will have no intervention. Short physical performance battery protocol and score sheet tool will be used as outcome measure tool. Participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective interventions after 3 months. Data will be analyzed on SPSS 21.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

September 4, 2020

Last Update Submit

March 26, 2021

Conditions

Keywords

Locomotive SyndromeGeriatricElastic Band Resistance Exercises.

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery Protocol and Score Sheet

    It is a clinician-rated physical measures that evaluates physical function in older adults. This assessment consist of 3 sub-scales: standing balance, gait , rising from chair . The assessment is scored on a 0-12 scale,with higher scores indicating better function. The SPPB does not require specific training ,is free to use and requires only a stopwatch and chair .

    12 Weeks

Study Arms (2)

GROUP A (Elastic Band Exercises)

EXPERIMENTAL

Warm up: for 10 min, Exercise: Lower limb exercises using elastic band for 30 min. Cool down: Self-stretches 5 min.

Other: Elastic Band Exercises

GROUP - B (No Intervention)

NO INTERVENTION

Routine activities of daily living

Interventions

Resistance exercise will be performed using theraband. The color of the band denotes the degree of elasticity and resistance level(yellow , red ,green ,blue, black or silver).Exercise load in terms of individual yielding elasticity (band color) in resistance training will set at a level that a patient perceived as somewhat hard, which is equivalent to a 13-grade rating (moderate intensity exercise) on the RPE, According to American College of Sports Medicine. For each exercise movement 3 sets of 10 repetitions of gentle concentric and eccentric contractions through the full range of motion will be slowly performed using a yellow Thera band initially. The exercise intensity will be increased when the patient is able to achieve a perceived yield strength corresponding to a 13- grade rating on the RPE scale.

GROUP A (Elastic Band Exercises)

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>60 years
  • Both genders
  • Greater than 16 score on Geriatric Locomotive Function Scale (GLFS)
  • Complaints related to legs and spine without disability in walking or going out.
  • Score of less than 45 in Berg Balance Scale.
  • Some difficulty in walking due to locomotive organ dysfunction.
  • Good communication and ability to perform activities of Short physical performance battery protocol.

You may not qualify if:

  • Persons with severe co-morbid conditins
  • Stroke
  • Cardiac failure
  • Cognitive impairment
  • Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • Akahane M, Yoshihara S, Maeyashiki A, Tanaka Y, Imamura T. Lifestyle factors are significantly associated with the locomotive syndrome: a cross-sectional study. BMC Geriatr. 2017 Oct 18;17(1):241. doi: 10.1186/s12877-017-0630-1.

    PMID: 29047351BACKGROUND
  • Akai M, Doi T, Seichi A, Okuma Y, Ogata T, Iwaya T. Locomotive Syndrome: Operational Definition Based on a Questionnaire, and Exercise Interventions on Mobility Dysfunction in Elderly People. Clin Rev Bone Miner Metab. 2016;14:119-130. doi: 10.1007/s12018-016-9210-8. Epub 2016 Jun 3.

    PMID: 27375372BACKGROUND
  • Iwaya T, Doi T, Seichi A, Hoshino Y, Ogata T, Akai M. Characteristics of disability in activity of daily living in elderly people associated with locomotive disorders. BMC Geriatr. 2017 Jul 26;17(1):165. doi: 10.1186/s12877-017-0543-z.

    PMID: 28747158BACKGROUND
  • Kataoka H, Miyatake N, Ichikawa H, Arakawa Y, Mori Y. Relationship of locomotive syndrome with health-related quality of life among patients with obstructive sleep apnea syndrome. J Phys Ther Sci. 2017 Jul;29(7):1129-1133. doi: 10.1589/jpts.29.1129. Epub 2017 Jul 15.

    PMID: 28744031BACKGROUND
  • Matsumoto H, Hagino H, Wada T, Kobayashi E. Locomotive syndrome presents a risk for falls and fractures in the elderly Japanese population. Osteoporos Sarcopenia. 2016 Sep;2(3):156-163. doi: 10.1016/j.afos.2016.06.001. Epub 2016 Jul 1.

    PMID: 30775481BACKGROUND

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 14, 2020

Study Start

August 24, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations