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A double-blind randomised controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

Abdulelah M. Aldhahir, Yousef S. Aldabayan, Jaber S. Alqahtani, Heidi A. Ridsdale, Colette Smith, John R. Hurst, Swapna Mandal
ERJ Open Research 2021 7: 00077-2021; DOI: 10.1183/23120541.00077-2021
Abdulelah M. Aldhahir
1UCL Respiratory, Royal Free Campus, University College London, London, UK
2Respiratory Therapy Dept, Faculty of Applied Medical Sciences, Jazan University, Jazan, Saudi Arabia
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  • ORCID record for Abdulelah M. Aldhahir
Yousef S. Aldabayan
1UCL Respiratory, Royal Free Campus, University College London, London, UK
3Respiratory Care Dept, College of Applied Medical Sciences, King Faisal University, Al-Hasa, Saudi Arabia
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Jaber S. Alqahtani
1UCL Respiratory, Royal Free Campus, University College London, London, UK
4Dept of Respiratory Care, Prince Sultan Military College of Health Sciences, Dammam, Saudi Arabia
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Heidi A. Ridsdale
5Central and North West London NHS Foundation Trust, London, UK
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Colette Smith
6Research Dept of Infection and Population Health, University College London, London, UK
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John R. Hurst
1UCL Respiratory, Royal Free Campus, University College London, London, UK
7Royal Free London NHS Foundation Trust, London, UK
8These authors contributed equally to this work
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  • For correspondence: j.hurst@ucl.ac.uk
Swapna Mandal
1UCL Respiratory, Royal Free Campus, University College London, London, UK
7Royal Free London NHS Foundation Trust, London, UK
8These authors contributed equally to this work
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  • FIGURE 1
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    FIGURE 1

    CONSORT recruitment diagram for enrolment and study completion. BMI: body mass index; ISWT: incremental shuttle walk test; FCP: Fortisip Compact Protein.

  • FIGURE 2
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    FIGURE 2

    Post-pulmonary rehabilitation incremental shuttle walk test (ISWT) distance in the control (305±148 m) and intervention groups (342±149 m) (p=0.10). Data are presented as mean and standard deviation.

Tables

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  • Supplementary Materials
  • TABLE 1

    Demographic data and baseline characteristics of the chronic obstructive pulmonary disease (COPD) patients who completed the study

    ControlInterventionp-value#
    Subjects2222
    Demographics
     Age years70±975±60.04*
     Sex0.53
      Male13 (59)15 (68)
      Female9 (41)7 (32)
     Active smoker10 (45)5 (23)0.20
     Ex-smoker12 (55)17 (77)
     Smoking history pack-years39 (24–59)45 (28–93)0.41
     Exacerbation within last year1 (0–2)0 (0–1)0.21
     Hospitalisation due to exacerbations within last year0 (0–1)0 (0–0)0.03*
    Medications
     SABA15 (68)15 (68)0.81
     LABA15 (68)9 (41)0.09
     SAMA00
     LAMA16 (73)8 (36)0.02*
     ICS12 (54)7 (32)0.16
     Nonrespiratory medications17 (77)20 (91)0.09
     Diabetes00
    Pulmonary function
     FEV1 L1.2 (1–2)1.6 (1–2)0.27
     FEV1 % pred52±1959±220.18
     FEV1/FVC %54±1253±130.90
    Anthropometric measurements
     Weight kg68±1375±160.12
     Waist circumference cm92±1496±150.46
     Hip circumference cm98±9104±110.04*
     Mid-thigh circumference cm56±859±60.16
    Body composition
     Fat mass kg24±726±60.50
     BMI kg·m−223±424±40.36
     Fat-free mass kg43±1049±130.12
     FFMI kg·m−215±316±30.17
    Functional outcomes
     ISWT m265±133269±1300.92
     mMRC grade3 (2–3)3 (2–3)0.87
     Right handgrip kg26±1930±100.15
     Left handgrip kg25±929±90.16
     STS5 s11 (7–13)10 (9–12)0.94
    Questionnaires
     CAT score20±818±60.37
     Anxiety (HADS) score6 (4–9)4 (3–10)0.42
     Depression (HADS) score6±35±30.19
     SGRQ total score52±1741±130.02*
     SGRQ symptoms score63±2352±210.14
     SGRQ activity score57 (57–86)57 (53–69)0.03*
     SGRQ impact score38±1927±120.03*
     MUST score0 (0–1)0 (0–0)0.50
    Physical activity steps·day−12663 (1947–4912)4297 (1726–7211)0.33

    Data are presented as n, mean±sd, n (%) or median (interquartile range), unless otherwise stated. SABA: short-acting β-agonist; LABA: long-acting β-agonist; SAMA: short-acting muscarinic antagonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; BMI: body mass index; FFMI: fat-free mass index; ISWT: incremental shuttle walk test; mMRC: modified Medical Research Council; STS5: five-repetition sit-to-stand test; CAT: COPD Assessment Test; HADS: Hospital Anxiety and Depression Scale; SGRQ: St George's Respiratory Questionnaire; MUST: Malnutrition Universal Screening Tool. #: p-values were calculated using the Chi-squared, paired t-test for normally distributed data and the Wilcoxon signed-rank test for nonnormally distributed data, and represent a comparison between the control and intervention groups. *: p<0.05.

    • TABLE 2

      Within- and between-group changes in functional outcomes, anthropometric measurements, body composition, health-related quality of life and physical activity following pulmonary rehabilitation#

      ControlInterventionBetween-group difference¶95% CIEffect sizep-value+
      PrePostPrePost
      Functional outcomes
       ISWT m265±133305±148269±129342±14932±85−5–702.70.10
       mMRC grade3 (2–3)3 (2–3)3 (2–3)3 (2–3)0 (0–0)01
       Right handgrip kg26±1929±930±1032±100.5±5−2–31.50.44
       Left handgrip kg25±928±1029±930±100.9±7−2–40.50.33
       STS5 s10 (7–13)8 (6–10)11 (9–12)9 (7–12)−1 (−4–0.3)−5–0.240.08
      Anthropometric measurements
       Weight kg68±1369±1375±1676±160.4±2−0.6–20.20.50
       Waist circumference cm94 (78–105)94 (77–102)93 (87–105)96 (85–111)1 (−3–1)1–30.10.38
       Hip circumference cm98±998±9104±11103±92±6−1–41.20.11
       Mid-thigh circumference cm56±858±659±661±50.4±6−2–30.050.75
      Body composition
       Fat mass kg26 (18–30)25 (18–30)27 (21–32)27 (19–33)2 (−2–4)−3–40.030.24
       Fat-free mass kg41 (34–52)42 (34–56)52 (37–61)49 (38–59)0.3 (−3–4)−2–50.30.88
       FFMI kg·m−215±315±316±317±40.1±2−1–10.0010.38
      Questionnaires
       CAT score20±819±818±617±70.04±8−3–30.120.98
       Anxiety (HADS) score7±46±56±55±50.4±3−1–210.55
       Depression (HADS) score6±36±35±34±40.5±3−1–20.030.39
       SGRQ total score52±1751±1741±1343±162±15−5–100.0060.48
       SGRQ symptoms score63±2357±2052±2149±273±28−11–170.060.76
       SGRQ activity score72±1871±1960±1766±216±21−5–160.50.20
       SGRQ impact score38±1936.6±2027±1228±160.5±18−9–100.0010.74
       MUST score0 (0–1)0 (0–1)0 (0–0)0 (0–0)0 (0–0)01
      Physical activity steps·day−12663 (1947–4912)2903 (1800–4753)4297 (1726–7211)5973 (2000–6812)31
      (−1421–1337)
      −974–13690.040.88

      Data are presented as mean±sd or median (interquartile range), unless otherwise stated. ISWT: incremental shuttle walk test; mMRC: modified Medical Research Council; STS5: five-repetition sit-to-stand test; FFMI: fat-free mass index; CAT: COPD Assessment Test; COPD: chronic obstructive pulmonary disease; HADS: Hospital Anxiety and Depression Scale; SGRQ: St George's Respiratory Questionnaire; MUST: Malnutrition Universal Screening Tool. #: control n=22 and intervention n=22; ¶: mean difference for each group was calculated by subtracting baseline from post-rehabilitation measurements; +: p-values were calculated using the paired t-test for normally distributed data and the Wilcoxon signed-rank test for nonnormally distributed data, and represent the change between the mean differences in the control and intervention groups.

      • TABLE 3

        Baseline characteristics between responders and nonresponders to the incremental shuttle walk test (ISWT) in the intervention group

        RespondersNonrespondersp-value
        Subjects139
        Demographics
         Age years74±578±60.15
         Sex0.90
          Male9 (69)6 (66)
          Female4 (31)3 (33)
         Ex-smoker10 (77)7 (78)0.96
         Smoking history pack-years49 (28–105)45 (21–49)0.34
         Exacerbation within last year5 (38)5 (56)0.43
         Hospitalisation due to exacerbations within last year0 (0)1 (11)0.22
        Anthropometric measurements
         Weight kg78±1471±180.32
         Waist circumference cm98±1292±180.33
         Hip circumference cm106±8102±150.44
         Mid-thigh circumference cm62±455±60.006*
        Pulmonary function
         FEV1 % pred59±2252±190.28
         FEV1/FVC %53±1354±120.75
        Body composition
         BMI kg·m−225±324±50.50
         Fat-free mass kg16±215±30.29
         FFMI kg·m−252±1345±140.38
        Functional outcomes
         ISWT m265±134274±1320.88
         mMRC grade3 (2–3)3 (2–3)0.95
         Right handgrip kg32±1228±80.45
         Left handgrip kg30±1027±80.43
         STS5 s11±311±40.89
        Questionnaires
         CAT score19±618±70.78
         Anxiety (HADS) score6 (2–13)3 (2–7)0.26
         Depression (HADS) score7±43±20.04*
         SGRQ total score42±1439±120.56
         MUST score0 (0–0)0 (0–2)0.36
        Physical activity steps·day−14909±28513930±34950.49

        Data are presented as n, mean±sd, n (%) or median (interquartile range), unless otherwise stated. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; BMI: body mass index; FFMI: fat-free mass index; mMRC: modified Medical Research Council dyspnoea scale; STS5: five-repetition sit-to-stand test; CAT: COPD Assessment Test; COPD: chronic obstructive pulmonary disease; HADS: Hospital Anxiety and Depression Scale; SGRQ: St George's Respiratory Questionnaire; MUST: Malnutrition Universal Screening Tool. *: p<0.05.

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        A double-blind randomised controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study
        Abdulelah M. Aldhahir, Yousef S. Aldabayan, Jaber S. Alqahtani, Heidi A. Ridsdale, Colette Smith, John R. Hurst, Swapna Mandal
        ERJ Open Research Jan 2021, 7 (1) 00077-2021; DOI: 10.1183/23120541.00077-2021

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        A double-blind randomised controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study
        Abdulelah M. Aldhahir, Yousef S. Aldabayan, Jaber S. Alqahtani, Heidi A. Ridsdale, Colette Smith, John R. Hurst, Swapna Mandal
        ERJ Open Research Jan 2021, 7 (1) 00077-2021; DOI: 10.1183/23120541.00077-2021
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