Exergame Study for Family Caregivers

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05032872

Acronym / sponsor ID

GoGrowExergrame #20104R

Conditions

Sedentary Lifestyle

Keywords

Family Caregivers

Study type

Interventional

Recruitment status

Completed

Enrolment

80 participants (actual)

Lead sponsor

Brandeis UniversityUniversity, hospital or other

Collaborators

National Institute on Aging (NIA)

Study start

16 Aug 2021 (actual)

Primary completion

31 Mar 2022 (actual)

Study completion

30 Apr 2022 (actual)

First posted

2 Sep 2021 (actual)

Results

Posted 19 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Basic science

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

2

Who may qualify

Ages

40 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percent Change in Steps

   Time frame: 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.

2. Lubben Social Network Scale (LSNS)

   Time frame: 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.

3. Social Connectedness Scale

   Time frame: 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.

4. UCLA Loneliness Scale

   Time frame: 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.

5. Positive and Negative Affect Schedule (PANAS) (20 Items)

   Time frame: 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).

6. Perceived Stress Scale (PSS)

   Time frame: 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).

7. Brief Symptom Inventory (BSI)

   Time frame: 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).

8. Caregiver's Stress Scale

   Time frame: 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.

9. International Physical Activity Questionnaire (IPAQ) Short Version

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36916022Lin XY, Zhang L, Yoon S, Zhang R, Lachman ME. A Social Exergame Intervention to Promote Physical Activity, Social Support, and Well-Being in Family Caregivers. Gerontologist. 2023 Oct 17;63(9):1456-1466. doi: 10.1093/geront/gnad028.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.