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NCT05032872

Exergame Study for Family Caregivers

Completed NA Results posted Last updated 19 July 2023
What this trial tests

NA trial testing Social Exergame Treatment Group in Sedentary Lifestyle in 80 participants. Completed in 30 April 2022.

Timeline
16 August 2021
Primary endpoint
31 March 2022
30 April 2022

Quick facts

Lead sponsorBrandeis University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposebasic science
Enrollment80
Start date16 August 2021
Primary completion31 March 2022
Estimated completion30 April 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brandeis University

Who can join

40 and older, any sex, with Sedentary Lifestyle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Steps Primary · Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8

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 From Baseline to Week 3
GroupValue95% CI
Social Exergame Treatment Group4.68± 29
Control Group4.77± 23
Percent Change From Baseline to Week 4
GroupValue95% CI
Social Exergame Treatment Group11.87± 33
Control Group2.69± 22
Percent Change From Baseline to Week 5
GroupValue95% CI
Social Exergame Treatment Group10± 46
Control Group11.11± 26
Percent Change From Baseline to Week 6
GroupValue95% CI
Social Exergame Treatment Group5.33± 38
Control Group11.26± 28
Percent Change From Baseline to Week 7
GroupValue95% CI
Social Exergame Treatment Group3.11± 35
Control Group5.66± 33
Percent Change From Baseline to Week 8
GroupValue95% CI
Social Exergame Treatment Group10± 48
Control Group-6.45± 24
Lubben Social Network Scale (LSNS) Primary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group32.32± 7.98
Control Group30.64± 9.26
Posttest
GroupValue95% CI
Social Exergame Treatment Group32.23± 9.81
Control Group28.40± 9.15
Social Connectedness Scale Primary · Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

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.

Knowing Others' Experience Baseline (Average of Week 1 and 2)
GroupValue95% CI
Social Exergame Treatment Group4.88± .92
Control Group4.72± 1.06
Knowing Others' Experience Week 3
GroupValue95% CI
Social Exergame Treatment Group4.7± 1.22
Control Group4.72± 1.18
Knowing Others' Experience Week 4
GroupValue95% CI
Social Exergame Treatment Group4.96± 1.23
Control Group4.87± 1.12
Knowing Others' Experience Week 5
GroupValue95% CI
Social Exergame Treatment Group4.85± 1.4
Control Group4.67± 1.17
Knowing Others' Experience Week 6
GroupValue95% CI
Social Exergame Treatment Group5± 1.14
Control Group4.67± 1.28
Knowing Others' Experience Week 7
GroupValue95% CI
Social Exergame Treatment Group4.63± 1.22
Control Group4.66± 1.27
Knowing Others' Experience Week 8
GroupValue95% CI
Social Exergame Treatment Group4.77± 1.31
Control Group4.70± 1.33
Relationship Salience Baseline (Average of Week 1 and 2)
GroupValue95% CI
Social Exergame Treatment Group4.55± 1.22
Control Group4.47± 1.36
UCLA Loneliness Scale Primary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group2.21± 0.63
Control Group2.21± 0.73
Posttest
GroupValue95% CI
Social Exergame Treatment Group2.08± 0.75
Control Group2.24± 0.76
Positive and Negative Affect Schedule (PANAS) (20 Items) Primary · Pretest (before week 1) and posttest (after week 8)

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).

Positive Affect Pretest
GroupValue95% CI
Social Exergame Treatment Group2.32± 0.85
Control Group2.13± 0.93
Positive Affect Posttest
GroupValue95% CI
Social Exergame Treatment Group2.14± 1.05
Control Group2.02± 1.03
Negative Affect Pretest
GroupValue95% CI
Social Exergame Treatment Group1.09± 0.80
Control Group0.9± 0.67
Negative Affect Posttest
GroupValue95% CI
Social Exergame Treatment Group1.00± 0.92
Control Group0.9± 0.74
Perceived Stress Scale (PSS) Primary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group23.08± 7.92
Control Group22.82± 8.66
Posttest
GroupValue95% CI
Social Exergame Treatment Group22.32± 8.44
Control Group22.20± 7.78
Brief Symptom Inventory (BSI) Primary · Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

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)
GroupValue95% CI
Social Exergame Treatment Group19.26± 12.07
Control Group21.01± 12.67
Week 3
GroupValue95% CI
Social Exergame Treatment Group20.55± 13.09
Control Group20.17± 13.96
Week 4
GroupValue95% CI
Social Exergame Treatment Group20.4± 14.7
Control Group20.44± 13.76
Week 5
GroupValue95% CI
Social Exergame Treatment Group19.65± 14.88
Control Group19.8± 13.21
Week 6
GroupValue95% CI
Social Exergame Treatment Group18.72± 15.03
Control Group19.2± 13.75
Week 7
GroupValue95% CI
Social Exergame Treatment Group20.17± 16.08
Control Group19.32± 13.79
Week 8
GroupValue95% CI
Social Exergame Treatment Group17.71± 15.83
Control Group19.69± 14.03
Caregiver's Stress Scale Primary · Pretest (before week 1) and posttest (after week 8)

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.

Overload Pretest
GroupValue95% CI
Social Exergame Treatment Group1.84± 0.92
Control Group1.61± 0.68
Overload Posttest
GroupValue95% CI
Social Exergame Treatment Group1.77± 0.80
Control Group1.58± 0.73
Relational Deprivation Pretest
GroupValue95% CI
Social Exergame Treatment Group1.97± 0.97
Control Group1.83± 0.85
Relational Deprivation Posttest
GroupValue95% CI
Social Exergame Treatment Group1.83± 0.86
Control Group1.83± 0.77
Job Caregiving Conflict Pretest
GroupValue95% CI
Social Exergame Treatment Group2.18± 0.72
Control Group2.11± 0.60
Job Caregiving Conflict Posttest
GroupValue95% CI
Social Exergame Treatment Group2.25± 0.73
Control Group2.27± 0.75
Role Captivity Pretest
GroupValue95% CI
Social Exergame Treatment Group1.88± 0.90
Control Group1.93± 0.83
Role Captivity Posttest
GroupValue95% CI
Social Exergame Treatment Group1.82± 1.02
Control Group2.13± 1.04
International Physical Activity Questionnaire (IPAQ) Short Version Primary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group1523.69± 1324.89
Control Group1234.46± 1382.82
Posttest
GroupValue95% CI
Social Exergame Treatment Group2066.86± 1482.13
Control Group1375.50± 1640.83
Exercise Self-Efficacy Secondary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group19.74± 6.31
Control Group19.10± 6.99
Posttest
GroupValue95% CI
Social Exergame Treatment Group22.87± 6.70
Control Group22.86± 6.68
Satisfaction With Life Scale Secondary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group19.84± 7.50
Control Group19.95± 7.95
Posttest
GroupValue95% CI
Social Exergame Treatment Group20.61± 7.43
Control Group18.66± 8.73
Sense of Control Secondary · Pretest (before week 1) and posttest (after week 8)

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
GroupValue95% CI
Social Exergame Treatment Group31.96± 6.05
Control Group29.77± 6.76
Posttest
GroupValue95% CI
Social Exergame Treatment Group31.10± 7.32
Control Group29.07± 7.82

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Social Exergame Treatment Group
Serious: 0/38 (0%)
Deaths: 0/38
Control Group
Serious: 0/42 (0%)
Deaths: 0/42
Other adverse events (1 terms — click to expand)

ReactionSystemSocial Exergame Treatment …Control Group
Broken AnkleInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT05032872 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Social Exergame Intervention to Promote Physical Activity, Social Support, and Well-Being in Family Caregivers.
    Lin XY, Zhang L, Yoon S, Zhang R, et al · · 2023 · cited 6× · PMID 36916022 · DOI 10.1093/geront/gnad028

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Other recruiting trials for Sedentary Lifestyle

Currently open trials in the same condition.

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