NCT04786132

Brief Summary

Currently, there is a growing concern for the elderly population and for what the increase in life expectancy entails, and that is why many authors investigate about exercise protocols that delay the appearance of both cognitive and motor diseases and how to link both in your day to day. Despite this, there is still little information about training with DT tasks that improve the life of the elderly and that is why this study aims to evaluate the effect of an eight-week training program in older adults healthy, in the improvement of balance and proprioception of the knee, with the inclusion of a cognitive task performed simultaneously. We hypothesize that the inclusion of the double motor-cognitive task in the training sessions will improve the performance in the balance and proprioception tests performed with the simultaneous cognitive task after 8 weeks compared to the control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

March 3, 2021

Last Update Submit

March 6, 2021

Conditions

Keywords

Dual TaskProprioceptionBalanceMusic

Outcome Measures

Primary Outcomes (3)

  • Motor control results

    Change from pre-test to post-test in motor control results. The bipedal and unipodal Romberg Test was performed to evaluate the balance of the subjects. Variants of open and closed eyes were applied for the bipedal test and dominance for the unipedal test, in order to find more difference between groups. These tests were performed on a force platform, considered a gold standard tool for the analysis of postural balance deficits, using valid parameters and confidence stabilometry measures. The recorded values were the area of the ellipse and the mean velocity in the anterior-posterior (MVAP) and medial-lateral (MVML) directions. While the area of the ellipse acts as an indicator of postural control performance, MVAP and MVML readings provide information on the neuromuscular activity used to maintain postural control (Frederic Noé \& Paillard, 2005). For all these variables, lower scores indicate better performance on tasks.

    Up to 8 weeks

  • Proprioception results

    Change from pre-test to post-test in proprioception results. The AEr45º in the dominant leg was recorded. This measurement was taken using the Goniometer Pro mobile app (2.9, 5Fuf5 co, Bloomfield, NJ, United States). It provides instantaneous, accurate, repeatable readings of the range of movement (ROM), measuring the difference between the required knee angle and the position that is observed (Mourcou et al., 2016). During the test, participant close their eyes, placed their knees at a 45º angle and maintain this position for six seconds and return to the original standing position. Afterwards they were told to bend their knees again until they had returned to exactly the same position the researcher had placed them in (i.e. 45º). In order to quantify conscious proprioception the absolute value of the difference between the requested (45º) and the actual angle was recorded to determine the participant's joint repositioning ability.

    Up to 8 weeks

  • Cognitive results

    Change from pre-test to post-test in cognitive results The cognitive task came from the subscale called "categorical evocation in associations", which is found within the battery of subscales of the Revised Barcelona Test (Peña-Casanova, 2005). The task consisted of mentioning the maximum number of possible words for 30 seconds belonging to the same semantic field. The semantic fields chosen were the following: 1. Animals; 2.Fruit; 3. Cities; 4. Parts of the body; 5. Garments; 6.Meals; 7. Countries; 8.Colors; 9. Names of women; 10. Names of men. The score obtained depends on the number of words remembered, scoring a point for each of them. No points were added to repeated words or synonyms (Peña-Casanova, 2005). To quantify the total number of words that the subjects said, they were recorded and once the tests were finished, the total of words mentioned in each repetition were counted.

    Up to 8 weeks

Secondary Outcomes (1)

  • Cognitive Reserve Results

    Only measured at the beginning of the intervention

Study Arms (2)

Dual Task (proprioception, balance and cognitive) training

EXPERIMENTAL

A DT training protocol of 8 weeks duration was carried out, during 2 days a week, with a duration of 30 minutes each session divided into: warm-up (mobility and warm-up 5 '), main part (20') and cool down (5 'dynamic stretching). The main part consisted of a choreography divided into five measures of thirty-two beats each, in turn divided into four parts of eight movements, which included proprioception and balance exercises such as: squats, imbalances, lateral movements, front, standing on one leg, twist, etc. The sessions evolved from individual exercises, in pairs, in trios and finally in groups. The sessions included music that was unknown to the subjects but at the same time easy to learn, so that while they performed the motor tasks, they would memorize the songs. The sessions were carried out by the main researcher who controlled both the technique of the exercises and motivated them to sing and perform a cognitive exercise.

Other: Cognitive-motor training

Proprioception and balance training

ACTIVE COMPARATOR

The control group training protocol is the same as the experimental group, whit the same duration and the same sessions, the unique difference is that there was no music included in the sessions, and therefore cognitive ability was not worked. The sessions were carried out by the main researcher who controlled the technique of the exercises and motivated the participant.

Other: Motor training

Interventions

A DT training protocol of 8 weeks duration was carried out, during 2 days a week, with a duration of 30 minutes each session divided into: warm-up (mobility and warm-up 5 '), main part (20') and cool down (5 'dynamic stretching). The main part consisted of a choreography divided into five measures of thirty-two beats each, in turn divided into four parts of eight movements, which included proprioception and balance exercises such as: squats, imbalances, lateral movements, front, standing on one leg, twist, etc. The sessions evolved from individual exercises, in pairs, in trios and finally in groups. The sessions included music that was unknown to the subjects but at the same time easy to learn, so that while they performed the motor tasks, they would memorize the songs. The sessions were carried out by the main researcher who controlled both the technique of the exercises and motivated them to sing and perform a cognitive exercise.

Dual Task (proprioception, balance and cognitive) training

A training protocol of 8 weeks duration was carried out, during 2 days a week, with a duration of 30 minutes each session divided into: warm-up (mobility and warm-up 5 '), main part (20') and cool down (5 'dynamic stretching). The main part consisted of a choreography divided into five measures of thirty-two beats each, in turn divided into four parts of eight movements, which included proprioception and balance exercises such as: squats, imbalances, lateral movements, front, standing on one leg, twist, etc. The sessions evolved from individual exercises, in pairs, in trios and finally in groups.

Proprioception and balance training

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Physically active older adults

You may not qualify if:

  • Clinical disability for physical activity
  • Neurological condition such as Alzheimer's or Parkinson's disease
  • Subjected to drug treatments that alter the normal functioning of the nervous system
  • Recent lower limb joint replacement surgery (12 months before testing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainhoa Nieto Guisado

Barcelona, 08022, Spain

Location

Related Publications (5)

  • Stern Y. Cognitive reserve. Neuropsychologia. 2009 Aug;47(10):2015-28. doi: 10.1016/j.neuropsychologia.2009.03.004. Epub 2009 Mar 13.

    PMID: 19467352BACKGROUND
  • Wang H, Ji Z, Jiang G, Liu W, Jiao X. Correlation among proprioception, muscle strength, and balance. J Phys Ther Sci. 2016 Dec;28(12):3468-3472. doi: 10.1589/jpts.28.3468. Epub 2016 Dec 27.

    PMID: 28174475BACKGROUND
  • Liu Y, Lachman ME. Education and Cognition in Middle Age and Later Life: The Mediating Role of Physical and Cognitive Activity. J Gerontol B Psychol Sci Soc Sci. 2020 Aug 13;75(7):e93-e104. doi: 10.1093/geronb/gbz020.

    PMID: 30955036BACKGROUND
  • Kim SJ, Yoo GE. Rhythm-Motor Dual Task Intervention for Fall Prevention in Healthy Older Adults. Front Psychol. 2020 Jan 17;10:3027. doi: 10.3389/fpsyg.2019.03027. eCollection 2019.

    PMID: 32010035BACKGROUND
  • Hiyamizu M, Morioka S, Shomoto K, Shimada T. Effects of dual task balance training on dual task performance in elderly people: a randomized controlled trial. Clin Rehabil. 2012 Jan;26(1):58-67. doi: 10.1177/0269215510394222. Epub 2011 Mar 18.

    PMID: 21421689BACKGROUND

Study Officials

  • Mónica Solana-Tramunt

    University Ramon Llull

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pre test, intervention and Post test. Experimental group performs and eight week dual task training with proprioception and balance exercise while including unknown sung music 2 days a week. Control group do the same protocol and the same days but without the inclusion of music.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 8, 2021

Study Start

October 5, 2019

Primary Completion

July 1, 2020

Study Completion

May 30, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations