NCT04577092

Brief Summary

Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study was to compare the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. The participants were divided into two groups; who received mCdtt (Group 1) and who received mMdtt (Group 2). The intervention program had lasted for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

September 25, 2020

Last Update Submit

September 30, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively

    baseline (first assessment)

  • Berg Balance Scale (BBS)

    BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively

    End of the training (8 weeks after)

Secondary Outcomes (6)

  • Falls Efficacy Scale International (FES-I)

    baseline (first assessment)

  • Falls Efficacy Scale International (FES-I)

    End of the training (8 weeks after)

  • Timed Up and Go (TUG)

    baseline (first assessment)

  • Timed Up and Go (TUG)

    End of the training (8 weeks after)

  • Muscle Testing (MT)

    baseline (first assessment)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Charlson Comorbidity Index (CCI)

    baseline (first assessment)

Study Arms (2)

Motor-Cognitive

ACTIVE COMPARATOR

In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.

Other: Warm-up exerciseOther: Motor-Cognitive exerciseOther: Cool-down exercise

Motor-Motor

ACTIVE COMPARATOR

In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. In cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.

Other: Warm-up exerciseOther: Motor-Motor exerciseOther: Cool-down exercise

Interventions

In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips.

Motor-CognitiveMotor-Motor

After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.

Motor-Cognitive

participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.

Motor-Motor

In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.

Motor-CognitiveMotor-Motor

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) age over 60 years old
  • (2) score ≥ 24 on the Mini-Mental State Exam
  • (3) category of walking ability ≥ 4 according to the Functional Ambulation Category
  • (4) no problem in visual ability and hearing

You may not qualify if:

  • (1) a history of specific balance problems (i.e., diagnosed neurological, musculoskeletal or vestibular disorder)
  • (2) history of cerebrovascular occasion
  • (3) history of hip-knee surgery
  • (4) use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, 34160, Turkey (Türkiye)

Location

Related Publications (1)

  • Akin H, Senel A, Taskiran H, Kaya Mutlu E. Do motor-cognitive and motor-motor dual task training effect differently balance performance in older adults? Eur Geriatr Med. 2021 Apr;12(2):371-378. doi: 10.1007/s41999-020-00434-8. Epub 2021 Jan 3.

MeSH Terms

Interventions

Warm-Up ExerciseCool-Down Exercise

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPost-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hanifegul Taskiran, PT, Prof

    Istanbul Aydın University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Sub-investigator, Physiotherapist, MSc

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 6, 2020

Study Start

September 1, 2017

Primary Completion

February 12, 2018

Study Completion

March 18, 2018

Last Updated

October 6, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations