Clinical trial NCT05032872: Exergame Study for Family Caregivers
Official title: Social Exergame Intervention to Promote Physical Activity, Social Support, And Well-Being in Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Family Caregivers
Lead sponsor: Brandeis University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-09-02
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to examine Go\&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

Detailed description: The study is a 2-week baseline and 6-week intervention aimed at comparing the feasibility and efficacy of an exergame (Go\&Grow without social contact components) and a social exergame (full version of Go\&Grow) in promoting physical activity, social support, and well-being in family caregivers. The study also seeks to test social support and physical activity as mechanisms for the relationships between condition (exergame non-social vs social exergame) and wellbeing. Participants will be randomly assigned using a random assignment generator to either the control condition (exergame non-social) or the treatment condition (social exergame) on a rolling basis. Participants from both conditions will be reminded daily via app-based notifications during the intervention period to wear their Fitbit and to play the game.

Eligibility criteria: Inclusion Criteria:

* Participants who are caregivers for a family member (e.g., relative, spouse, friend) who is 65 years or older and is either frail, has a disability, or has at least one chronic illness
* 40 years or older
* Own an Android smartphone with Google play store/internet access
* Able to walk for at least 20 minutes at a time
* Comfortable wearing a fitness tracker for the duration of the study
* Familiar with smartphone app usages
* Comfortable with using the study-related app for the duration of the study

Exclusion Criteria:

* Had a recent (within the past 6 months) cardiovascular event or fall.
* Currently participating in any other physical activity study/intervention
* Currently own or use a Fitbit or other activity tracking watches
* Knows someone who is participating or has participated in the study
* Currently physically active (exercise regularly 3 times a week or more for at least 30 minutes)
* More than 2 errors on the Short Portable Mental Status Questionnaire (Pfeiffer, 1975).

Primary outcomes:
measure: Percent Change in Steps
timeFrame: Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8
measure: Lubben Social Network Scale (LSNS)
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Social Connectedness Scale
timeFrame: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
measure: UCLA Loneliness Scale
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Positive and Negative Affect Schedule (PANAS) (20 Items)
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Perceived Stress Scale (PSS)
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
measure: Caregiver's Stress Scale
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: International Physical Activity Questionnaire (IPAQ) Short Version
timeFrame: Pretest (before week 1) and posttest (after week 8)
Secondary outcomes:
measure: Exercise Self-Efficacy
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Satisfaction With Life Scale
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Sense of Control
timeFrame: Pretest (before week 1) and posttest (after week 8)
measure: Exergame Enjoyment Questionnaire (EEQ)
timeFrame: Posttest (after week 8)
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Brandeis University
state: Massachusetts
Study officials:
References: