NCT02773121

Brief Summary

The goal of this research study is to examine whether an intervention to increase physical activity using a body-worn sensor affects cognitive (thinking) processes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

May 11, 2016

Last Update Submit

April 19, 2020

Conditions

Keywords

CognitionLearningMemoryExecutive FunctionAttentionNeuropsychological TestsPhysical ActivityPhysical FitnessExerciseResistance TrainingWalkingMuscle Stretching ExercisesExercise TestBalanceFlexibilityBody Composition

Outcome Measures

Primary Outcomes (2)

  • Cognition

    Change in cognitive task performance post-intervention compared to baseline

    80-90 minutes

  • Aerobic Fitness

    Change aerobic fitness measured with treadmill test post-intervention

    30 minutes

Secondary Outcomes (4)

  • Functional fitness: Five Times Sit to Stand

    10 min

  • Functional fitness: Timed Get Up and Go

    10 min

  • Functional fitness: Flexibility

    10 min

  • Physical activity

    12 weeks

Other Outcomes (3)

  • Gait: step and stride time

    12 weeks

  • Gait: stride time variability

    12 weeks

  • Gait: gait symmetry

    12 weeks

Study Arms (2)

Physical activity monitoring

EXPERIMENTAL

Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their physical activity level to at least 150 min of moderate-intensity physical activity per week. They will be asked to follow guidelines in the "Go4Life" brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises.

Behavioral: Physical Activity

Flexibility and balance

ACTIVE COMPARATOR

Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their balance and flexibility over the 12 week period of the intervention. They will be asked to follow guidelines in the "Go4Life" brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises.

Behavioral: Physical Activity

Interventions

Trainer-guided at-home behavioral intervention

Flexibility and balancePhysical activity monitoring

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking
  • Age between 55-85 years
  • Sedentary status (physically inactive; not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months)
  • Generally healthy men and women
  • Living in the greater Boston area
  • Available for the 4 month duration of the study
  • Native-English speaking or fluent in English (must have attended elementary school and higher in English)

You may not qualify if:

  • Poor vision that cannot be corrected with glasses or contact lenses
  • Presence of an acute infection
  • Diagnosis of kidney failure
  • Diagnosis of liver disease
  • Diagnosis of thyrotoxicosis/hyperthyroidism
  • Diagnosis of cancer
  • Past or present conditions that affect cognitive functioning:
  • learning disability
  • neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
  • psychiatric disorders or conditions (depression, anxiety disorder, etc.)
  • Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and moderate-intensity physical activity:
  • heart conditions (e.g. heart attack, arrhythmias, etc.)
  • circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)
  • respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
  • current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Kern KL, Storer TW, Schon K. Cardiorespiratory fitness, hippocampal subfield volumes, and mnemonic discrimination task performance in aging. Hum Brain Mapp. 2021 Mar;42(4):871-892. doi: 10.1002/hbm.25259. Epub 2020 Dec 16.

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karin Schon, Ph.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 16, 2016

Study Start

March 1, 2017

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations