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Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain.

ABSTRACT: Background Osteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce barriers to physical activity. We developed and tested a brief, novel behavioral intervention for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity. Methods A randomized feasibility and acceptability pilot trial compared Engage-PA to treatment as usual plus fitness tracker (TAU+) in N=40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-minute telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and value-guided action). The impact of COVID-19 on general wellbeing and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t -tests to assess for between-group differences. Results Feasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention "mostly" or "very" helpful. Engage-PA participants demonstrated improvements in arthritis pain severity ( M _diff =1.68, p <.05), arthritis-related physical functioning ( M _diff =.875, p =.056), and self-reported activity ( M _diff =.875, p <.05) from baseline to post-treatment as compared to TAU+. Sixty-three percent of participants provided useable objective daily steps data. Other secondary outcome patterns were not interpretable in this small sample. COVID-19 added additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active. Conclusions Engage-PA is a promising brief, novel behavioral intervention that has potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of the intervention is particularly notable as most participants reported COVID-19 added more barriers to physical activity, and Engage-PA may be appealing in future studies. Trial Registration: clinicaltrials.gov, NCT04490395, registered 7/29/2020, https://clinicaltrials.gov/ct2/show/NCT04490395.

SUBMITTER: Vilardaga JCP

PROVIDER: S-EPMC8750708 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundOsteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce physical activity barriers. We developed and tested a brief, novel behavioral intervention (i.e., Engage-PA) for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity.MethodsA randomized feasibility and acceptability pilot trial compared Engage-PA to treatment-as-usual plus fitness tracker (TAU+) in N = 40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-min telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and valued living). The impact of COVID-19 on general well-being and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t-tests to assess for between-group differences.ResultsFeasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention "mostly" or "very" helpful. Engage-PA participants demonstrated improvements in arthritis pain severity (Mdiff = 1.68, p = 0.044, 95% CI [- 0.26, 3.62]) and self-reported activity (Mdiff = 0.875, p = 0.038, 95% CI [- 1.85, 0.98]) from baseline to post-treatment as compared to TAU+. Due to pandemic-related challenges, there was a high level of missing data (43%) for daily steps, but available data showed no significant change in steps over time or between the groups. COVID-19 added an additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active.ConclusionsEngage-PA is a promising brief, novel behavioral intervention with the potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of Engage-PA are particularly notable as most participants reported COVID-19 added more barriers to physical activity.Trial registrationClinicalTrials.gov, NCT04490395 . Registered on July 29, 2020.

Project description:ObjectivesTo determine the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease.Design and settingIn Part A of this two-part study, adolescents with SCD and chronic pain (Group 1) and their parent (Group 2) completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. In Part B, the study assessed the feasibility and safety of an instructor-led group yoga program. The study was registered on clinicaltrials.gov (NCT03694548).InterventionEight instructor-led group yoga sessions.Main outcome measuresFeasibility and safety outcomes were chosen a priori, as follows: 1) Proportion of adolescent patients with SCD and chronic pain approached that consent to participate in Part A, 2) Proportion of adolescent participants enrolled in Part A that consent to participate in Part B, 3) Proportion of participants enrolled in Part B that attend at least 6 of 8 yoga sessions, 4) Proportion of participants enrolled in Part B with an ED visit or a hospitalization for pain within 24 h of completion of each yoga session, 5) Proportion of participants in Part B who complete all study assessments before, and at the end of the yoga program, 6) Adherence to submission of pain diary.ResultsThe median age of 15 patient participants in Part A was 16 (IQR 14-17), and 14 parents was 43.5 (IQR 42-51). Most participants were female. Most participant responses indicated a positive opinion of yoga. Nine adolescents (60 %) from Part A participated in Part B of the study. The median age of 9 participants in Part B was 17 (IQR 15-18), and 5 of the 9 participants were female (53.3 %). Only one participant was able to attend 3 of the 8 yoga sessions offered, and did not experience any ED visits or hospitalizations following the yoga sessions. None of the other feasibility endpoints were met in this study.ConclusionsPatients with SCD and chronic pain overall have a positive opinion of yoga, but there are challenges with recruitment and retention of participants in a clinical trial of yoga, and barriers to feasibility of an in-person group yoga intervention.

Project description:ObjectiveVirtual reality (VR) has the potential to improve pain and pain-related symptoms. We examined the feasibility, acceptability, safety, and impact of a 30-min virtual underwater/sea environment (VR Blue) for reducing pain and pain-related symptoms in advanced colorectal cancer patients. A qualitative exit interview was conducted to understand preferences, thoughts, and feelings about the VR session.MethodParticipants (N = 20) had stage IV colorectal cancer and moderate-to-severe pain. Participants completed a 30-min VR Blue session that visually and aurally immersed them in virtual ocean scenarios. Feasibility was assessed by accrual (N = 20), protocol adherence (≥80% completing VR Blue), and completed data (≥80% assessment completion). Acceptability was determined by patients reporting ≥80% intervention satisfaction. Safety was determined by ≥80% of patients completing the session without self-reported side effects. Measures of pain, tension, relaxation, stress, anxiety, and mood were collected before, during, and after the VR Blue session. A semi-structured qualitative interview was conducted after VR Blue to assess participants' VR experiences.ResultsAll participants (100%) completed the VR Blue session. There was 100% data collection at the pre- and post-assessments. Satisfaction with VR Blue was high M = 3.3 (SD = 0.4) (83%). No significant side effects were reported. Pain decreased by 59% (Pre-M = 3 [1]; Post-M = 1 [1]). Tension decreased by 74% (Pre-M = 30 [24]; Post-M = 8 [13]). Relaxation improved by 38% (Pre-M = 62 [21]); Post-M = 86 [17]). Stress decreased by 68% (Pre-M = 24 [24]; Post-M = 8 [14]). Anxiety decreased by 65% (Pre-M = 20 [23]; Post-M = 7 [13]). Mood improved by 70% (Pre-M = 13 [16]; Post-M = 4 [11]). Qualitative data suggested a positive response to the VR Blue protocol.Significance of resultsThis work supports the feasibility, acceptability, and safety of VR Blue for advanced colorectal cancer patients. Participants showed significant pre-post improvement in pain and pain-related symptoms hinting to the potential feasibility of VR interventions in this population. Larger, randomized trials with a control condition are needed to examine the efficacy of VR-based interventions for patients with advanced colorectal cancer and pain.

Project description:BackgroundMultiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.ObjectiveWe sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability.MethodsRandomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES).ResultsSixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy.ConclusionThere was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.

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Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain.

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