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Physical Activity for Cognitive Impairment (TALIEHO Trial)

N/A

Recruiting

Led By Kathryn Schmitz, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 65-84 years

Female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 14-15

Awards & highlights

TALIEHO Trial Summary

This trial is testing whether a light-intensity physical activity intervention can improve the health of obese, older adult breast cancer survivors, compared to usual care.

Who is the study for?

This trial is for older adult female breast cancer survivors, aged 65-84, who are obese with a BMI ≥30 and have been post-treatment for 1-10 years. Participants should drink alcohol minimally, be fluent in English, mentally sharp as per specific tests, and have their doctor's approval. Those very active or with serious health issues affecting participation are excluded.Check my eligibility

What is being tested?

The study is testing if light-intensity physical activity done at home can improve the health of these women compared to those receiving usual care without this exercise program. It's a small-scale test where participants are randomly assigned to one of the two groups.See study design

What are the potential side effects?

Since this trial involves light-intensity exercise, side effects might include muscle soreness or strain. However, because it's gentle activity designed for older adults, severe side effects are not commonly expected.

TALIEHO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 65 and 84 years old.

Select...

I am female.

TALIEHO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Markers of inflammation: C-reactive protein

Secondary outcome measures

Ability to Participate in Social Roles and Activities

Acceptability-the proportion of older adults who agree to participate

Alcohol Use Disorder

+22 more

TALIEHO Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 Intervention

Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.

Group II: Physical activityExperimental Treatment1 Intervention

the physical activity intervention will be structured to increase light-intensity aerobic physical activity, to achieve a total of 150 minutes per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity

2019

Completed Phase 3

~4710

0 / 2Eligibility criteria met