NCT03493373

Brief Summary

This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

April 4, 2018

Last Update Submit

March 25, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Gait velocity

    Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated

    Baseline

  • Gait velocity

    Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated

    9 weeks

  • Gait velocity

    Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated

    3 months

Secondary Outcomes (15)

  • Pain intensity

    Baseline

  • Pain intensity

    9 weeks

  • Pain intensity

    3 months

  • Pain location

    Baseline

  • Pain location

    9 weeks

  • +10 more secondary outcomes

Study Arms (2)

Exercise and nervous system mobilization

EXPERIMENTAL

This group will receive neural mobilization and therapeutic exercise: two sessions of 60 minutes during 8 weeks.

Other: ExerciseOther: Neural mobilization

Exercise

EXPERIMENTAL

This group will receive therapeutic exercise: two sessions of 60 minutes during 8 weeks.

Other: Exercise

Interventions

The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.

ExerciseExercise and nervous system mobilization

Neural gliding mobilization will target mainly the lower limb nerves and will be performed in series of 10 repetitions with 1 minute interval between series.

Exercise and nervous system mobilization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • be 65 years of age or older;
  • to have independent gait with or without technical aid;
  • have indication of the institution's doctor for participation in the study

You may not qualify if:

  • inability to understand study aims.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lar Santa Catarina do Reboleiro

Guarda, 3810-193, Portugal

Location

Lar da Santa Cruz da Beselga

Guarda, Portugal

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 10, 2018

Study Start

April 15, 2018

Primary Completion

December 15, 2018

Study Completion

December 21, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations