Effects of Simultaneous or Sequential Combination of Physical and Cognitive Training

NCT ID: NCT03614182

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2021-05-31

Brief Summary

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of simultaneous or sequential combination of physical and cognitive training on dual-task walking and cognitive performance for community-dwelling healthy older adults.

Detailed Description

English Synopsis

I. Title of Study:

Effects of simultaneous or sequential combination of physical and cognitive training on dual-task walking performance for community-dwelling healthy older adults: a randomized controlled trial.

II. Study Objectives:

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of simultaneous or sequential combination of physical and cognitive training on dual-task walking and cognitive performance for community-dwelling healthy older adults. Specifically, the study aims to test: 1) the psychometric properties (i.e., test-retest reliability and validity) of dual-task walking outcome measures, 2) the effectiveness of delivering physical and cognitive training via simultaneous or sequential way (physical training concurrent to or followed by a cognitive training) on improving dual-task walking for healthy older adults by using good psychometric properties of outcome measures, 3) the changed CMI pattern of older adults after simultaneous or sequential physical and cognitive training.

III. Study Design A metric analysis and comparative efficacy research will be conducted at medical center(s). Sixty community-dwelling ambulatory healthy older adults will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the six dual-task walking assessments will include two types of walking conditions (walking at preferred speed and fast speed) and simultaneously perform three cognitive tasks (Serial Three Subtractions, Stroop, and Auditory Stroop tasks). These three cognitive tasks represent different domains of cognitive function: working memory and executive function. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest) and dual-task Timed-up-and-Go test (dual-TUG) obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between older fallers and non-fallers to examine discriminant validity of dual-task assessments.

A comparative efficacy research is a single-blind, randomized controlled trial. Sixty healthy elderly will be randomized to physical training concurrent with cognitive training (P+C, n=20), or physical training followed by cognitive training (P-then-C, n=20), or physical training without cognitive training (P, n=20) groups. The P+C group will undertake standing balance, stepping, and treadmill walking training while concurrently perform cognitive tasks. The P-then-C group will train the same set of standing balance, stepping, and treadmill walking activities as the P+C group while followed by cognitive training later. The P group will only train the same set of standing balance, stepping, and treadmill walking activities as the other two groups. All three groups will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up). Two baselines, 12 week, and 24 week data will be analyzed using multivariate statistical analyses and groups will be compared on treatment related changes in dual-task walking and cognitive performance among participants. To determine comparative effectiveness of interventions on primary outcomes (dual-task walking speed and composite score of cognitive tasks), two way mixed repeated measure ANOVAs will be used.

A blinded assessor will administer four assessments. All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing 3 cognitive tasks) at two baselines, post intervention, and 3-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Berg Balance Scale, Mini-BESTest, dual-TUG, Functional Gait Assessment, Physical Activity Scale for the Elderly, Activities-Specific Balance Confidence Scale, Chair Stand Test, hand-held dynamometers, and Geriatric Depression Scale Short Form. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.

Number of Planned Patients: 60 healthy older adults Duration of the Study: 2018/08/01～2021/07/31

Conditions

Healthy Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

physical training concurrent with cognitive training

The physical training concurrent with cognitive training group (the P+C group) will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Group Type: EXPERIMENTAL

physical training concurrent with cognitive training

Intervention Type: DEVICE

The P+C group will undertake standing balance, stepping, and treadmill walking training while concurrently perform cognitive tasks.

physical training followed by cognitive training

The physical training followed by cognitive training will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Group Type: ACTIVE_COMPARATOR

physical training followed by cognitive training

Intervention Type: DEVICE

The P-then-C group will train the same set of standing balance, stepping, and treadmill walking activities as the P+C group while followed by cognitive training later.

physical training without cognitive training

The physical training without cognitive training group will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Group Type: ACTIVE_COMPARATOR

physical training without cognitive training

Intervention Type: DEVICE

The P group will only train the same set of standing balance, stepping, and treadmill walking activities as the other two groups.

Interventions

physical training concurrent with cognitive training

The P+C group will undertake standing balance, stepping, and treadmill walking training while concurrently perform cognitive tasks.

Intervention Type: DEVICE

physical training followed by cognitive training

The P-then-C group will train the same set of standing balance, stepping, and treadmill walking activities as the P+C group while followed by cognitive training later.

Intervention Type: DEVICE

physical training without cognitive training

The P group will only train the same set of standing balance, stepping, and treadmill walking activities as the other two groups.

Intervention Type: DEVICE

Other Intervention Names

P+C; P-then-C; P

Eligibility Criteria

Inclusion Criteria

• age more than 65 years old
• able to walk 10 m;
• no severe vision, hearing, cognition, and language problems.

Exclusion Criteria

• neurological or musculoskeletal diagnosis that affects walking
• unable standing for at least 2 minutes,
• MMSE score <24 or severe uncorrected visual deficits
• moderate to severe high blood pressure (systolic pressure ≧ 160mmHg and diastolic blood pressure ≧ 100mmHg )

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Li-Ling Chuang

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung University

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

201702091B0

Identifier Type: -

Identifier Source: org_study_id