Participants were enrolled in order of initial contact. Twelve participants (n = 12 female) were recruited over 43 days. Figure 2 shows a diagram of the participant flow. Nine participants were recruited via posts from the Danish Fibromyalgia & Pain Association, and three were recruited via social media. Following participant enrollment, an additional 10 patients responded to the recruitment posts over the subsequent two weeks.
Fig. 2One participant withdrew from the study due to an illness unrelated to the study. Table 2 shows the demographic and clinical characteristics of the participants.
Table 2 Demographic and clinical characteristicsThe total time spent on weekly follow-ups with the 12 participants via the app amounted to 2.5 h over the study period, equating to less than 20 min per participant across the six weeks. Log data revealed that the majority of contacts during the study were initiated by the principal investigator (MPS).
Qualitative resultsTwo online focus-group interviews were conducted in May 2024. Eight of the 11 participants were able to participate in the interviews. One participant declined the invitation, one was unavailable due to work engagements, and one fell ill on the interview day. Each online focus group interview involved four respondents and lasted approximately 60 min.
Based on the qualitative interviews, we identified four major themes. Three themes emerged relating to the acceptability of the intervention, while one theme pertained to the research processes. The major themes were: (1) Factors motivating participation, (2) The advantages of exercising at home, (3) Influence of weekly communication and (4) Potential areas for improvement. Three of the four major themes were divided into subthemes. Codes, major themes and subthemes are summarised in Fig. 3.
Fig. 3Codes, major themes and subthemes identified through the inductive analysis
Theme 1: factors motivating participationFactors motivating participation describe a theme that catches the participants´ perspectives on what drove their incentive to participate in the study. It comprises three sub-themes, each addressing the variability in factors that encouraged participation.
1.Contributing to the development of better treatment options.
The participants expressed that they often feel overlooked by the traditional healthcare system. This manifested as both challenges in accessing effective treatments and a perceived lack of research on developing new treatments for FM. Consequently, they feel obligated to contribute to developing new therapies when possible.
“No one’s helping us, so I figured I’d donate my body for this; it couldn’t possibly hurt, and I might learn something new.” (pt. 4).
Furthermore, the participants also pointed out a profound sense of shared responsibility, suggesting that individuals with the means and resources to participate in research should do so for the benefit of others.
“I believe you should do everything you can to help others with fibromyalgia in the future.” (pt. 5).
2.Learning how to incorporate exercise into everyday life.
The participant expressed that a motive for participation was to learn more about incorporating exercise into their daily life. Many previously led active lives, but following their diagnosis, their tolerance for physical activity had declined to a point where they found it increasingly difficult to cope with basic activities of daily living, much less implement new physical activities.
“I know that staying active is good for me. I used to be very active, but since my diagnosis, I’ve had trouble understanding how I respond to physical activity. I often have setbacks when I start something new.” (pt. 4).
Moreover, participants expressed confusion about how to increase their physical activity levels. They wanted to integrate exercise into their daily routines while managing family and work responsibilities, but struggled to find the mental and physical energy to do so.
“I feel a bit lost. I used to be active, but I don’t have the energy or mental space for it. I want to find a compromise where I can exercise a little and still manage my work and family life, but it’s hard with this diagnosis.” (pt. 1).
3.A belief that the intervention was manageable.
The participants shared that the description of the home-based intervention was an encouraging factor for participation. Many had a negative perception of physical exercise, attributing it to increased FM symptoms. However, stretching exercises carried a more positive connotation. Accordingly, the participants felt that the intervention was something they could manage.
“I associate exercise with something unpleasant that makes me very tired, but this (stretching intervention) felt easier to manage.” (pt. 2).
Theme 2: the advantages of exercising at homeThe advantages of exercising at home describe a theme that emerged from the participants´ perspectives on how the home-based intervention fitted into their daily lives. It comprises two sub-themes, each addressing different aspects of how the participants experienced blending the exercises into daily life.
1.The exercises integrate well into daily life.
The participants shared positive experiences with fitting the exercises into their daily schedule and incorporating them into their daily routines despite balancing work and family responsibilities.
“I fit the exercises into my evenings because the mornings are all about getting the kids ready for school and myself ready for work.” (pt. 3).
One participant even described how the exercises became fun and engaging for her kids.
“The kids enjoyed it, so we often did the exercises together, me and the little girls, whenever it fit into our day.”(pt. 8).
2.Exercises are convenient, even on rough days.
The participants highlighted that the exercises were convenient and gentle. This meant they could perform the exercises even when their symptoms were most severe without exacerbating them.
“I get so tired these days that it hurts deep in my bones, but even though I’m completely drained and it feels like everything is a mess, I can still do the exercises.”(pt. 3).
Theme 3: influence of weekly communicationThe influence of weekly communication describes a theme that emerged from the participants´ perspectives on the influence of weekly communication with the principal investigator via the mHealth application. Some participants experienced the need to modify specific exercises during the trial, but found it easy and convenient to use the app to seek advice on making individual adjustments to address the challenges.
“At one point, I had an issue with one of the exercises, but it was easy to just write (to the principal investigator) and ask for advice.” (pt. 5).
Most participants did not feel the need to communicate with the principal investigator during the trial. While they responded to the weekly messages, they did not initiate contact themselves. Still, they found comfort in knowing that assistance and guidance were available.
“It was comforting to know that if you had questions or needed help, someone was always there for you.” (pt. 8).
The participants expressed that while they did not view the monitoring negatively, the weekly communication helped them stay consistent with the exercises.
“It’s comforting to know he (the principal investigator) is there. It is reassuring to know that you are not just doing the exercises for no reason, but that there is someone on the other end with whom you are helping and doing something together.” (pt. 5).
Theme 4: potential areas for improvementPotential areas for improvement describe a theme that emerged from the participants´ perspectives on the study design and intervention, offering ways to enhance the study’s impression. It comprises two sub-themes, addressing different aspects of factors related to areas for improvement.
1.Obstacles to successful participant recruitment.
A key participant observation was the identification of potential obstacles to recruitment for this kind of intervention study. The participants expressed that they might be among the better-functioning patients, as not all people with FM share their energy level or mental fortitude. They explained that for many, the thought of doing exercises daily, even if for just six minutes, could present a barrier to participation:
“Not everyone shares our level of energy. For some, doing the exercises daily, even for six minutes, could simply, on the face of it, be an overwhelming challenge.”(pt. 4).
Furthermore, the participant also voiced concerns about how best to promote the study and establish contact with potential participants. They revealed that they have private social media groups where FM patients can exchange experiences and build connections, but these groups are accessible only with permission from current members.
“We’re not registered anywhere, so it’s hard to get in touch with us. We have private groups on Facebook, but you need permission to join them.” (pt. 2).
2.Adapting exercises to meet individual abilities.
The participants highlighted that although stretching exercises generally have a positive connotation, it might be necessary to clearly state that the exercises can be adjusted to individual needs to attract those with moderate to severe limitations in functional capacity.
“It’s important to emphasise that the exercises can be adjusted to accommodate different needs.”(pt. 4).
Quantitative outcomesSince one participant was not assessed post-intervention, an intention-to-treat analysis was used with the baseline evaluation for FIQ-R, SF-36, pressure pain thresholds and range of motion measures carried forward. Mean values ± SD and percentage differences for FIQ-R, SF-36, pressure pain thresholds and range of motion are presented in Table 3.
Table 3 Absolute values (means (SD) and percentage differences) for secondary outcomesFIQ-RThere were clinically relevant improvements in the FIQ-R Total score (mean change = 12 ± 8.3; p = 0.003), function (mean change = 2.5 ± 3.4; p = 0.036), symptoms (mean change = 6.8 ± 4.6; p = 0.005), overall impact (mean change = 3.2 ± 3.6; p = 0.015), and stiffness (mean change = 1.3 ± 2.1; p = 0.041). There were, however, no clinically relevant differences in pain (mean change = 1.2 ± 1.9; p = 0.065).
SF-36There were clinically relevant improvements in PCS (mean change = 3.8 ± 5.3; p = 0.026) and MCS (mean change = 5.4 ± 6.1; p = 0.013).
Pressure pain thresholds and range of motionThere were no clinically relevant changes in flexibility (mean change = 1.8°±14.9; p = 0.515) or pain sensitivity (mean change > 2.8 ± 23.6; p > 0.130).
Self-perceived physical activityThere was a significant increase in the participants’ self-perceived physical activity levels (MET score) (p = 0.021).
Adherence to the interventionFor self-reported adherence, data from the 11 participants who completed the intervention and were assessed post-intervention are reported. The self-reported adherence rate was 91% (± 6.9%).
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