An augmented prescribed exercise program (APEP) to improve mobility of older acute medical patients – a randomized, controlled pilot and feasibility trial

Abstract

Background There is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study. Methods We conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions. Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20–30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay. Results Thirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions. There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%. Conclusions This small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study. Trial registration German Clinical Trials Register ( DRKS00011262 ). Registered 27 October 2016. Electronic supplementary material The online version of this article (10.1186/s12877-019-1246-4) contains supplementary material, which is available to authorized users.

The impact of interventions on management of frailty in hospitalized frail older adults: a systematic review and meta-analysis

“…Seven studies were included in the systematic review [ 11 , 21 , 22 , 29 – 31 ]; four of these studies [ 22 , 29 , 31 ] reported outcomes of the same clinical trial project. One of four studies [ 22 ] reported about frailty and the three other studies [ 22 , 29 , 31 ] published secondary outcomes relevant for the present systematic review.…”

“…Also, it seems that multidimensional interventions covering physical, psychological and social functioning of hospitalized frail older patients are more effective than one dimension interventions [33]. This is supported by a study using the APEP intervention [21], which was targeted on individual physiotherapy and didn't consider the social and psychological aspects of frail older adults; APEP was less effective on the degree of frailty. However, further clinical trials studies with long-term follow up are needed to confirm this hypothesis.…”

“…Moreover, the mHELP intervention was effective on prevention of weight loss in the intervention group [11,22,29]. Also, Braun et al (2019) demonstrated no statistically significance between the intervention group and control group [21], probably caused by the low number of participants. Our findings are consistent with the systematic review conducted by Kidd et al (2019) reporting that physical performance in frail older adults was improved with interventions to increase physical activity [24].…”

“…All studies were poor in "Blinding of participants and personnel". [21] and all other studies demonstrated poor quality [11,22,[29][30][31] (Additional file 2).…”

“…Frailty is thought to be manageable in hospital with interventions such as physiotherapy [ 21 ], nutrition therapy [ 11 ], and comprehensive geriatric care (CGA) [ 22 ]. Several systematic reviews were conducted to determine the most effective interventions to reduce frailty in elderly people.…”