Andrew J. Kittelson

Background: Exercise interventions are among the best-known interventions for cancer-related fatigue (CRF). Rural survivors of cancer, however, report specific barriers to engaging in exercise programs and lack overall access to effective programs. Objective: The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with CRF. Methods: A single-arm clinical trial of the BfitBwell Telehealth Program was performed. Based on an established clinical program, this adapted 12-week program addressed barriers previously reported by rural survivors by providing synchronous videoconference exercise sessions (2 per program), asynchronous exercise sessions using a personal training smartphone or internet app (3-5 per week), and regular symptom (CRF) monitoring using automated emailed surveys (every 2 weeks). Personalized exercise prescriptions containing aerobic and resistance activities were implemented by cancer exercise specialists. Symptom-triggered synchronous sessions were initiated for participants failing to improve in CRF, as identified by a reference chart of CRF improvements observed during a supervised exercise program. Eligible participants were adult survivors of any cancer diagnosis who had completed treatment with curative intent in the past 12 months or had no planned changes in treatment for the duration of the study, lived in a rural area, and were currently experiencing CRF. Feasibility was assessed by objective measures of recruitment, data collection, intervention acceptability and suitability, and preliminary evaluations of participant responses. CRF was the primary clinical outcome (assessed using the Functional Assessment of Chronic Illness Therapy—Fatigue Scale [FACIT-Fatigue]) and was measured before, after, and 6 months after program completion. Results: In total, 19 participants enrolled in the study, 16 initiated the exercise program, and 15 completed the program. A total of 14 participants were recruited through internet advertisements, and the total recruitment rate peaked at 5 participants per month. Participants completed 100% of initial and final assessments (30 assessments across all participants) and 93% (70/75 possible surveys across all participants) of emailed surveys and attended 97% (29/30 possible sessions across all participants) of synchronous exercise sessions. In total, 6 participants initiated symptom-triggered sessions, with 6 of 7 initiated sessions attended. The mean FACIT-Fatigue scores significantly improved (P=.001) by 11.2 (SD 6.8) points following the completion of the program. A total of 13 participants demonstrated at least a minimal clinically important difference in FACIT-Fatigue scores (≥ +3 points) at this time. FACIT-Fatigue scores did not significantly change from program completion to 6-month follow-up (n=13; mean change –1.1, SD 3.4 points; P=.29). Conclusions: Results from this investigation support the feasibility of the BfitBwell Telehealth Program and a subsequent efficacy trial. Novel program components also provide potential models for improving exercise program efficacy and efficiency through asynchronous exercise prescription and symptom monitoring. Trial Registration: ClinicalTrials.gov NCT04533165; https://clinicaltrials.gov/study/NCT04533165

BACKGROUND Exercise interventions are among the best-known interventions for cancer-related fatigue (CRF). Rural survivors of cancer, however, report specific barriers to engaging in exercise programs and lack overall access to effective programs. OBJECTIVE The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with CRF. METHODS A single-arm clinical trial of the BfitBwell Telehealth Program was performed. Based on an established clinical program, this adapted 12-week program addressed barriers previously reported by rural survivors by providing synchronous videoconference exercise sessions (2 per program), asynchronous exercise sessions using a personal training smartphone or internet app (3-5 per week), and regular symptom (CRF) monitoring using automated emailed surveys (every 2 weeks). Personalized exercise prescriptions containing aerobic and resistance activities were implemented by cancer exercise specialists. Symptom-triggered synchronous sessions were initiated for participants failing to improve in CRF, as identified by a reference chart of CRF improvements observed during a supervised exercise program. Eligible participants were adult survivors of any cancer diagnosis who had completed treatment with curative intent in the past 12 months or had no planned changes in treatment for the duration of the study, lived in a rural area, and were currently experiencing CRF. Feasibility was assessed by objective measures of recruitment, data collection, intervention acceptability and suitability, and preliminary evaluations of participant responses. CRF was the primary clinical outcome (assessed using the Functional Assessment of Chronic Illness Therapy—Fatigue Scale [FACIT-Fatigue]) and was measured before, after, and 6 months after program completion. RESULTS In total, 19 participants enrolled in the study, 16 initiated the exercise program, and 15 completed the program. A total of 14 participants were recruited through internet advertisements, and the total recruitment rate peaked at 5 participants per month. Participants completed 100% of initial and final assessments (30 assessments across all participants) and 93% (70/75 possible surveys across all participants) of emailed surveys and attended 97% (29/30 possible sessions across all participants) of synchronous exercise sessions. In total, 6 participants initiated symptom-triggered sessions, with 6 of 7 initiated sessions attended. The mean FACIT-Fatigue scores significantly improved (P=.001) by 11.2 (SD 6.8) points following the completion of the program. A total of 13 participants demonstrated at least a minimal clinically important difference in FACIT-Fatigue scores (≥ +3 points) at this time. FACIT-Fatigue scores did not significantly change from program completion to 6-month follow-up (n=13; mean change –1.1, SD 3.4 points; P=.29). CONCLUSIONS Results from this investigation support the feasibility of the BfitBwell Telehealth Program and a subsequent efficacy trial. Novel program components also provide potential models for improving exercise program efficacy and efficiency through asynchronous exercise prescription and symptom monitoring. CLINICALTRIAL ClinicalTrials.gov NCT04533165; https://clinicaltrials.gov/study/NCT04533165

Background: After lower limb amputation, several prosthesis design options exist. However, prosthesis design decisions do not always reflect a prosthesis user’s needs, values, and preferences. Objective: To develop a patient decision aid (PDA) prototype for prosthetists and new prosthesis users facing prosthesis design decisions after lower limb amputation, and to assess its usability, accuracy, and comprehensibility. Study design: Exploratory mixed methods. Methods: PDA development was informed by a qualitative needs assessment and guided by the International Patient Decision Aid Standards. The PDA was evaluated by steering groups of experienced prosthesis users and prosthetic professionals (prosthetists and researchers) to test usability, accuracy, and comprehensibility through focus groups, individual interviews, and rating on a Likert scale ranging from 1 to 10. Results: The resulting PDA included 6 sections: (1) Amputation and Early Recovery, (2) Communication, (3) Values, (4) Prosthesis Design, (5) Preferences, and (6) Prosthetic Journey. Usability, accuracy, and comprehensibility were rated as 9.2, 9.6, and 9.6, respectively, by prosthetic professionals, and 9.4, 9.6, and 9.6, respectively, by prosthesis users. Discussion: The PDA incorporated guidance by relevant stakeholders and was rated favorably, emphasizing a need for shared decision-making support in prosthesis design. One challenge was determining the amount of information in the PDA, highlighting the diversity in end users’ informational needs. Future iterations of the PDA should undergo beta testing in clinical settings. Conclusions: A standardized, iterative method was used to develop a PDA for new lower limb prosthesis users and prosthetists when considering prosthesis design decisions. The PDA was considered useable, accurate, and comprehensible.

Background To support the optimisation of supervised exercise therapy (SET) in patients with intermittent claudication, we developed personalised outcomes forecasts (POFs), which visualise estimated walking distance and quality of life for individual patients. The POFs may enable healthcare professionals, such as physical and exercise therapists, to improve shared decision-making and patient outcomes. Objectives To assess differences in patient outcomes (functional walking distance, maximal walking distance and health-related quality of life) and the level of shared decision-making before and after the implementation of POFs in the conservative treatment of patients with intermittent claudication. Methods An interrupted time series design was used to compare preimplementation and postimplementation differences on patient outcomes. Using routinely collected data, differences from baseline to 6 months were compared between patients before and patients after the implementation. To compare levels of shared decision-making, we conducted observations of initial consults within a sample of physical or exercise therapists both before and after the implementation. Audiorecords of observations were scored on shared decision-making using the OPTION-5 instrument. Results Differences in improvements between patients with whom POFs were discussed (n=317) and patients before the implementation of POFs (n=721) did not reach statistical significance for both functional walking distance (experimental vs. control=+23%, p=0.11) and maximal walking distance (experimental vs. control=+21%, p=0.08). For health-related quality of life, the POFs-informed patients showed a statistically significant greater improvement of 4% (p=0.04). Increased levels of shared decision-making were observed in postimplementation consults (n=20) when compared with preimplementation consults (n=36), as the median OPTION-5 total score showed a statistically significant increase from 45 to 55 points (p=0.01). Conclusions Integrating POFs into daily practice of SET for patients with intermittent claudication could assist in improving health-related quality of life and enhancing patient involvement. Using POFs did not result in statistically significant different improvements between groups on walking distances. Trial registration number NL8838.

Background: Prosthesis design is complex and multiple appropriate options exist for any individual with lower-limb amputation. However, there is insufficient evidence for guiding decision-making. Shared decision-making (SDM) offers an opportunity to incorporate patient-specific values and preferences where evidence is lacking for prosthesis design decisions. To develop resources to facilitate SDM, and consistent with the International Patient Decision Aid Standards, it is necessary to identify the decisional needs of prosthetists and prosthesis users for prosthesis design decisions. Objectives: To assess the needs of prosthetists and new prosthesis users for SDM about the first prosthesis design. Study design: Qualitative descriptive design. Methods: Six focus groups were conducted with 38 prosthetists. Individual semistructured interviews were conducted with 17 new prosthesis users. Transcripts were analyzed using directed content analysis, with codes defined a priori using existing frameworks for SDM: the Three Talk Model for SDM and the Ottawa Decision Support Framework. Results: Four main themes were identified among prosthetists and prosthesis users: acknowledging complexity in communication, clarifying values, recognizing the role of experience to inform preferences, and understanding the prosthetic journey. Conclusions: Resources that support SDM for the first prosthesis design should consider methods for identifying individual communication needs, support with clarifying values, and resources such as experience for achieving informed preferences, within the context of the overall course of rehabilitation and recovery following lower-limb amputation. The themes identified in this work can inform SDM to promote collaborative discussion between prosthetists and new prosthesis users when making prosthesis design decisions.

The purpose of this study was to (1) determine the psychometric properties of the 25- and 10-item Connor-Davidson Resilience Scales (CD-RISC25, CD-RISC10) for people with lower-limb amputation (LLA) in middle age or later, and (2) describe relationships of the CD-RISC with biopsychosocial, sociodemographic, and health variables. Participants were included if their most recent LLA was 1 or more years prior, if they were independently walking with a prosthesis, and if they were between 45 and 88 years of age (N = 122; mean = 62.5 years of age [SD = 8]; 59.5 [mean = 58] months since LLA; 88.5% male; 82.0% with dysvascular etiology; 68.0% with unilateral transtibial LLA). Psychometric analyses included assessment of skewness, floor and ceiling effects, internal consistency, and agreement between versions. Correlation analyses were used to determine associations between the CD-RISC with disability, perceived functional capacity, falls efficacy, life-space, anxiety, depression, self-efficacy, social support, sociodemographic, and health variables. Additionally, quartiles of participants were identified using CD-RISC25 and CD-RISC10 scores and compared using ANOVA and post-hoc comparisons for disability, perceived functional capacity, falls efficacy, and life-space. Skewness, floor, and ceiling effects of both CD-RISC versions were acceptable. Both versions of the CD-RISC were internally consistent (CD-RISC25: α = .92; CD-RISC10: α = .89). The CD-RISC25 and CD-RISC10 were highly correlated with disability, perceived functional capacity, falls efficacy, anxiety, depression, and self-efficacy (r = 0.52–0.67). CD-RISC25 and CD-RISC10 quartile differences, especially the lowest quartile, were identified for disability, perceived functional capacity, falls efficacy, and life-space. The CD-RISC25 and CD-RISC10 have acceptable psychometric properties for use with people who have LLA. CD-RISC scores are associated with clinically relevant biopsychosocial measures targeted by physical therapist intervention following LLA. The CD-RISC may be an appropriate tool to measure resilience following LLA.

Background: Quadriceps weakness is a hallmark of total knee arthroplasty and is driven by reduced voluntary muscle activation following the surgical procedure. The mechanisms underlying postoperative activation deficits are not well established, although nociception has been implicated via both spinal reflex and supraspinal pathways. The purpose of this study was to assess the role of nociception in postoperative recovery of strength and activation. Methods: A total of 53 participants were assessed prior to total knee arthroplasty and at 6 weeks postoperatively. Quadriceps strength was measured by maximum voluntary isometric contraction, and activation was measured by the doublet interpolation technique. The pressure-pain threshold was used to measure local sensitization (at the knee joint) and systemic sensitization (at the forearm). Changes in outcomes (strength and activation) were regressed against pressure-pain threshold measurements. Mediation analyses were planned for significant associations to investigate whether deficits in voluntary activation were implicated on a causal pathway between pressure-pain threshold measures and postoperative strength loss. Results: Knee pressure-pain threshold measures were significantly associated with reduced voluntary quadriceps activation (beta = −0.04; p = 0.009) and diminished quadriceps strength after total knee arthroplasty (beta = −0.07; p = 0.001). There was also a mediation effect of voluntary activation on the relationship between the knee pressure-pain threshold and quadriceps strength. After correcting for multiple comparisons, relationships between the forearm pressure-pain threshold and strength and activation did not reach significance. Conclusions: The measures of local nociceptor sensitization were related to reduced strength and activation following total knee arthroplasty. This is consistent with a causal pathway linking increased firing of knee joint nociceptors to reduced activation and reduced strength. Future randomized studies should investigate whether peripherally directed pain therapies reduce pain while also promoting the recovery of quadriceps strength via an improved capacity for voluntary activation. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.