Exergame Study for Family Caregivers

Sedentary Lifestyle Clinical Trial

Official title:

Social Exergame Intervention to Promote Physical Activity, Social Support, And Well-Being in Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032872
• Other study ID #: GoGrowExergrame #20104R
• Secondary ID: P30AG048785
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2022
• Source: Brandeis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Social Exergame Treatment Group
Physical activity tracking, walk to grow flowers and plant their own garden Follow workout tutorials Daily steps tracked by Fitbit and workout log tracked by the app Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens In-app rewards (unlock new flowers to grow each week) if participants post stories
• Control Group
Physical activity tracking, walk to grow flowers and plant their own garden Follow workout tutorials Daily steps tracked by Fitbit and workout log tracked by the app Daily reminders to wear Fitbit and use the app

Locations

Country	Name	City	State
United States	Brandeis University	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brandeis University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Steps	Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step.; Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps.	Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8
Primary	Lubben Social Network Scale (LSNS)	Self-report measure of social support from the Lubben Social Network Scale for family and friends with scores summed across 18 items. Possible scores range from 0-60, with higher scores indicating higher social support.	Pretest (before week 1) and posttest (after week 8)
Primary	Social Connectedness Scale	Social Connectedness Scale was administered weekly during the intervention with the following subscales: relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity and quality, and dissatisfaction with contact quantity. Scores were averaged across items from each subscale and possible scores ranged from 1 to 7 with higher scores indicating a higher level of the subscale.	Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
Primary	UCLA Loneliness Scale	The UCLA Loneliness Scale captures one's subjective feelings of loneliness over the past week for weekly surveys and over the past month for pretest and posttest surveys (20 items with ratings from 1 "Never" to 4 "Often"). The scores were averaged across the 20 items, with a score ranging from 1-4. A higher score indicates more loneliness.	Pretest (before week 1) and posttest (after week 8)
Primary	Positive and Negative Affect Schedule (PANAS) (20 Items)	Positive and Negative Affect Schedule (PANAS) (20 items) asks participants to report how often participants felt positive and negative feelings over the past week for weekly surveys, and over the past month for pre-test and post-test surveys. Scores were averaged across the items (Total positive and negative affect scores can range from 0-4, with a higher score indicating a higher level of positive affect or negative affect).	Pretest (before week 1) and posttest (after week 8)
Primary	Perceived Stress Scale (PSS)	Perceived Stress Scale (PSS) asks participants' stress perception over the last month and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).	Pretest (before week 1) and posttest (after week 8)
Primary	Brief Symptom Inventory (BSI)	Brief Symptom Inventory (BSI) captures participants' psychological distress over the past week, scores were summed across the items (Total score ranges from 0-72, with higher scores indicating more stress) (Derogatis, 1975).	Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
Primary	Caregiver's Stress Scale	Caregiver's Stress Scale has a series of subscales based on a conceptual model of caregivers' stress: overload, relational deprivation, job and caregiving conflict, role captivity, sense of self, caregiving competence, personal gain, management of situation, management of meaning, management of distress, and expressive support. Each subscale ranges from 1 (strongly disagree) to 4 (strongly agree), and each subscale was averaged (with possible score ranging from 1-4) so that higher scores would indicate a higher value.	Pretest (before week 1) and posttest (after week 8)
Primary	International Physical Activity Questionnaire (IPAQ) Short Version	International Physical Activity Questionnaire - Short Version. A continuous score was calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs*min*days) + (Mod METs*min*days) + Vig METs*min*days). A higher score means a higher level of physical activity.	Pretest (before week 1) and posttest (after week 8)
Secondary	Exercise Self-Efficacy	9 items assessed how certain participants will exercise under certain circumstances (e.g., when you are feeling under pressure or when you are away from home). Items are assessed from 1 (very sure) to 4 (not at all sure). Items were reverse coded and summed across all items with a score ranging from 9 to 36. A higher score indicates higher exercise self-efficacy.	Pretest (before week 1) and posttest (after week 8)
Secondary	Satisfaction With Life Scale	Items are assessed from 1 (disagree strongly) to 7 (agree strongly) summed across all items, ranging from 5-35. A higher score indicates a higher satisfaction with life.	Pretest (before week 1) and posttest (after week 8)
Secondary	Sense of Control	items were used to assess sense of control. For example: "There is little I can do to change many of the important things in my life." Items are assessed from 1 (strongly disagree) to 7 (strongly agree) and reverse coded. A sum across all items was calculated ranging from 6-42. A higher score indicates a higher sense of control.	Pretest (before week 1) and posttest (after week 8)
Secondary	Exergame Enjoyment Questionnaire (EEQ)	Exergame Enjoyment Questionnaire (EEQ) was included in the posttest, which measured how much participants enjoyed the exergame (Fitzgerald et al., 2020). 20 items ranged from strongly disagree (1) to strongly agree (5) were summed. Scores rannged from 20 - 100, with a higher score indicating more exergame enjoyment.	Posttest (after week 8)