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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04577092
Other study ID # 13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date March 18, 2018

Study information

Verified date September 2020
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study is comparing 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. A total of 50 participants aged 60 and over (mean age: 67.72±7.33 years), having a score ≥ 24 on the Mini-Mental State Exam (MMSE), being in category of walking ability ≥ 4 according to the Functional Ambulation Category (FAC), having no problem in visual ability and hearing were included for this study. The participants who received mCdtt (Group 1) counted back from the two-digit number and the participants who received mMdtt (Group 2) held half-filled glasses with 90o flexion elbow with both hand while performing exercises. The intervention program had lasted for 8 weeks. To assess balance, fear of falling, walking functionality and muscle strength of participants, Berg Balance Scale (BBS), Falls Efficacy Scale International (FES-I), Timed Up and Go (TUG) and Hand-held dynamometer were used, respectively.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 18, 2018
Est. primary completion date February 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria:

- (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

Exclusion Criteria:

- (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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Warm-up exercise
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-Cognitive exercise
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-Motor exercise
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.
Cool-down exercise
In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.

Locations

Country Name City State
Turkey Istanbul Aydin University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Charlson Comorbidity Index (CCI) CCI was used to measure the comorbidity status of participants. It investigates existence of 17 comorbidities. The final score indicates disease burden and is a good estimator of mortality. baseline (first assessment)
Primary 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)
Primary 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 Falls Efficacy Scale International (FES-I) FES-I evaluates concerns about falling with 16 items consisting of social and physical activities. Each item can be replied as 1=not all concerned, 2=somewhat concerned 3=fairly concerned and 4=very concerned. Total score is in a range between 16 and 64, a higher score means higher concern about falling. baseline (first assessment)
Secondary Falls Efficacy Scale International (FES-I) FES-I evaluates concerns about falling with 16 items consisting of social and physical activities. Each item can be replied as 1=not all concerned, 2=somewhat concerned 3=fairly concerned and 4=very concerned. Total score is in a range between 16 and 64, a higher score means higher concern about falling. End of the training (8 weeks after)
Secondary Timed Up and Go (TUG) (TUG) test is a common, simple and quick test for the function, balance, gait and risk of fall assessment. The TUG was showed to be the most evidence-supported functional measure to evaluate risk of falls in older adults. To perform the test, the participants were asked to seat armchair with back support which was 46 cm above from the floor. The participants were instructed to stand up, walk a distance of 3 meters away from the seat as fast as possible, turn, walk back to seat and sit down. The time passed during this maneuver was recorded as seconds with a chronometer. baseline (first assessment)
Secondary Timed Up and Go (TUG) (TUG) test is a common, simple and quick test for the function, balance, gait and risk of fall assessment. The TUG was showed to be the most evidence-supported functional measure to evaluate risk of falls in older adults. To perform the test, the participants were asked to seat armchair with back support which was 46 cm above from the floor. The participants were instructed to stand up, walk a distance of 3 meters away from the seat as fast as possible, turn, walk back to seat and sit down. The time passed during this maneuver was recorded as seconds with a chronometer. End of the training (8 weeks after)
Secondary Muscle Testing (MT) MT was performed with Hand-held dynamometer (Lafeyette Instrument®, Lafeyette, IN) to assess power and ability for stability, in this study. Antigravity muscles (m. gluteus maximus, m. quadriceps femoris, m. gastrocnemius and m. tibialis anterior) were assessed while performing maximal volunteer isometric contraction (MVIC) and values were recorded as kg. N-1. baseline (first assessment)
Secondary Muscle Testing (MT) MT was performed with Hand-held dynamometer (Lafeyette Instrument®, Lafeyette, IN) to assess power and ability for stability, in this study. Antigravity muscles (m. gluteus maximus, m. quadriceps femoris, m. gastrocnemius and m. tibialis anterior) were assessed while performing maximal volunteer isometric contraction (MVIC) and values were recorded as kg. N-1. End of the training (8 weeks after)
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